- The study analyzed 211 semen analysis reports from laboratories in West Bengal, India to determine adherence to WHO 2010 guidelines.
- It found that while 92.4% of reports mentioned abstinence period, only 48.8% and 24.6% mentioned collection time and examination time, respectively.
- Details of collection such as site, completeness, and method were mentioned in 49.3%, 48.3%, and 30.8% of reports.
- Liquefaction time was mentioned in 77.3% of reports, but often without reference to WHO 2010 standards.
- ART laboratories were generally more adherent than non-ART laboratories in documenting collection details.
Standardization of Thyroid Function Tests, 05 05 - 2017Ola Elgaddar
Standardization of thyroid function tests is important to ensure comparable results across laboratories. For tests of total T3 and T4, a reference measurement system exists using primary calibrators and isotope dilution mass spectrometry. For free T3 and T4, a conventional reference measurement procedure was established using equilibrium dialysis and liquid chromatography tandem mass spectrometry. For TSH, the measurand was defined as intact total TSH accounting for glycosylation, and an "All Procedure Trimmed Mean" statistical approach using multiple commercial assays on patient samples was adopted as a surrogate reference measurement procedure.
Varicocele repair improves pregnancy rates in men with clinical varicoceles and abnormal semen quality. A meta-analysis of 7 randomized clinical trials found surgical varicocele repair significantly increased pregnancy rates compared to observation alone for men with clinical varicoceles and abnormal semen. The analysis showed no significant difference in pregnancy rates between repair and observation for studies that included men with subclinical varicoceles or normal semen quality. Surgical repair may be an effective first-line treatment for infertility in men with clinical varicoceles and abnormal semen parameters.
This document provides an overview of pathology and laboratory coding. It describes various areas of pathology including anatomical pathology, cytopathology, cytogenetics, microbiology, surgical pathology, and reproductive medicine procedures. For each area, it provides the code ranges and notes on how to report specific tests and procedures. It also provides examples of how to code common pathology cases.
The document discusses the design of clinical trials. It introduces key elements of protocol design such as research background, objectives, flowchart, randomization, inclusion/exclusion criteria, control groups, outcome measures, sample size calculation, data collection, and statistical analysis. It also provides examples of different types of clinical trial designs including randomized controlled trials.
This document provides guidelines on appropriate use of common laboratory tests, including indications, non-indications, and minimum frequencies for re-testing. It covers topics in haematology, clinical chemistry, microbiology, and immunology. The guidelines aim to promote quality healthcare and ensure the highest clinical practice standards while reducing unnecessary testing.
High variability in PK can be a characteristic of certain drug products which require different from ordinary strategies and study designs for establishing bioequivalence.
This document discusses bioequivalence standards for highly variable drug products. It begins by defining highly variable drug substances and products as those with intra-subject variabilities greater than 30%. It notes the sources of high variability can include administration conditions, physiological factors, and technical aspects. The usual standards for passing bioequivalence require average AUC and Cmax values to fall within 80-125% intervals. However, these criteria may be impossible to meet for highly variable drugs even with large sample sizes. The document therefore proposes alternative approaches for demonstrating bioequivalence of highly variable drugs, including replicate study designs and reference scaled average bioequivalence criteria. It provides examples and discusses some issues that can arise with these alternative approaches.
Standardization of Thyroid Function Tests, 05 05 - 2017Ola Elgaddar
Standardization of thyroid function tests is important to ensure comparable results across laboratories. For tests of total T3 and T4, a reference measurement system exists using primary calibrators and isotope dilution mass spectrometry. For free T3 and T4, a conventional reference measurement procedure was established using equilibrium dialysis and liquid chromatography tandem mass spectrometry. For TSH, the measurand was defined as intact total TSH accounting for glycosylation, and an "All Procedure Trimmed Mean" statistical approach using multiple commercial assays on patient samples was adopted as a surrogate reference measurement procedure.
Varicocele repair improves pregnancy rates in men with clinical varicoceles and abnormal semen quality. A meta-analysis of 7 randomized clinical trials found surgical varicocele repair significantly increased pregnancy rates compared to observation alone for men with clinical varicoceles and abnormal semen. The analysis showed no significant difference in pregnancy rates between repair and observation for studies that included men with subclinical varicoceles or normal semen quality. Surgical repair may be an effective first-line treatment for infertility in men with clinical varicoceles and abnormal semen parameters.
This document provides an overview of pathology and laboratory coding. It describes various areas of pathology including anatomical pathology, cytopathology, cytogenetics, microbiology, surgical pathology, and reproductive medicine procedures. For each area, it provides the code ranges and notes on how to report specific tests and procedures. It also provides examples of how to code common pathology cases.
The document discusses the design of clinical trials. It introduces key elements of protocol design such as research background, objectives, flowchart, randomization, inclusion/exclusion criteria, control groups, outcome measures, sample size calculation, data collection, and statistical analysis. It also provides examples of different types of clinical trial designs including randomized controlled trials.
This document provides guidelines on appropriate use of common laboratory tests, including indications, non-indications, and minimum frequencies for re-testing. It covers topics in haematology, clinical chemistry, microbiology, and immunology. The guidelines aim to promote quality healthcare and ensure the highest clinical practice standards while reducing unnecessary testing.
High variability in PK can be a characteristic of certain drug products which require different from ordinary strategies and study designs for establishing bioequivalence.
This document discusses bioequivalence standards for highly variable drug products. It begins by defining highly variable drug substances and products as those with intra-subject variabilities greater than 30%. It notes the sources of high variability can include administration conditions, physiological factors, and technical aspects. The usual standards for passing bioequivalence require average AUC and Cmax values to fall within 80-125% intervals. However, these criteria may be impossible to meet for highly variable drugs even with large sample sizes. The document therefore proposes alternative approaches for demonstrating bioequivalence of highly variable drugs, including replicate study designs and reference scaled average bioequivalence criteria. It provides examples and discusses some issues that can arise with these alternative approaches.
This review aimed to evaluate interventions for managing external root resorption in permanent teeth. No randomized controlled trials meeting the inclusion criteria were identified. External root resorption has various classifications and causes, including trauma, orthodontic treatment, and pressure from adjacent teeth. Potential treatments include root canal treatment, surgery to remove resorbed tissue, splinting mobile teeth, and extraction. However, there is no consensus on managing different forms of external root resorption due to a lack of high-quality evidence. Future research is needed in the form of randomized controlled trials.
This document provides guidelines for sterility testing of therapeutic goods in Australia. It discusses regulatory aspects and the rationale for sterility testing. It provides guidance on sampling lots for testing, including minimum numbers of items to sample based on batch size. It also lists the minimum quantities of products that should be tested from each container. The guidelines aim to provide a rigorous yet efficient approach to sterility testing to ensure therapeutic goods meet standards for quality and safety.
This document provides an overview of clinical trial design. It discusses the typical phases of clinical trials including:
- Phase I which focuses on safety and dose escalation
- Phase II which screens for therapeutic activity and further evaluates toxicity
- Phase III which uses a proper control group to further evaluate efficacy and monitors long-term safety
It also describes various study designs including randomized controlled trials, parallel designs, cross-over designs, and cohort studies. Key aspects of each design like advantages, disadvantages, and implementation are covered. The document provides a comprehensive yet concise primer on clinical trial methodology.
Environmental scans versus horizon scans; systematic reviews versus rapid rev...Kimberly Yang
Talk comparing environmental scans with horizon scans, systematic reviews, rapid reviews, and core outcome sets, presented to Center for Medical Technology Policy (CMTP) staff by Kimberly F. Yang on September 28, 2015
Biochemical tests in clinical medicine lect1MUDASSAR ANWER
This document discusses biochemical tests in clinical medicine. It covers topics such as the role of clinical biochemistry laboratories in disease diagnosis and treatment monitoring, common analyses performed, and diseases investigated using these tests. It also addresses the uses of biochemical tests in diagnosis, screening, prognosis, and treatment, as well as factors that can affect test results and their interpretation.
summary report of inspections of clinical trials conducted from April 2004 to...mahmoudnasseri
This document summarizes Health Canada inspections of clinical trials conducted from 2004 to 2011. During this period, 329 inspections found 3148 observations of non-compliance, mostly related to quality systems/procedures and record keeping. 92% of inspections were rated compliant and 8% non-compliant. Common deficiencies included lack of standard operating procedures, inadequate documentation and personnel training. The report aims to increase awareness of regulatory requirements and improve compliance for protecting clinical trial participants.
Effects of Intralesional Triamcinalone injection following Internal Urethroto...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
This document discusses predicting patient risk of acquiring Klebsiella pneumoniae carbapenemase producing organisms (KCPO) and linking environmental exposure to patient acquisition. It describes developing a patient risk model using a case-control approach and clinical and demographic data. A naïve Bayesian model was built and validated, showing an AUC of 0.746. It then analyzes the impact of positive room environments on patient infection using a treatment effects model, controlling for patient risk and length of stay. The results show room positivity is significantly associated with acquisition of infection, with an odds ratio of 22.25. Ultimately, interventions like hopper covers and heater traps reduced environmental transmission.
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
This presentation is aimed at presenting the issues associated with subgroup analyses in clinical trials: the different types of subgroup analyses and the statistical issues associated with the conduct of subgroup analyses.
Semen analysis as per WHO and clinical implicationsSandro Esteves
This document discusses semen analysis, new WHO reference values from 2010, and implications for clinical management. Key points include:
- Semen analysis provides biomarkers to predict fertility potential but has limitations on its own.
- The 2010 WHO reference values were derived from a meta-analysis of recent father studies and established new lower cut-off limits.
- The new WHO values resulted in many patients being reclassified from abnormal to normal ranges, especially for morphology, and impacted referral patterns, treatment recommendations, and access to ART.
- A comprehensive male fertility evaluation requires more than just a semen analysis and should include history, physical exam, hormones, and advanced sperm testing to properly diagnose and manage cases.
Quality Improvement in an AF Ablation ProgramJose Osorio
Atrial fibrillation ablation is an important treatment options for patients with AF. The number of AF ablations continue to rise annually but there is a limited number of Electrophysiology Laboratories and doctors. With the increasing prevalence of Afib, many institutions are finding bottlenecks with the increase volume.
We propose that a quality improvement initiative is the ideal way to improve efficiency, outcomes and safety of AF ablations with the end results being more patients treated with good results.
Driving Point of Care Technology Development: Integrated Approach to Consensu...CFTCC
The WALEX process combines facilitated discussion and discrete choice experiments to define the attributes of a realistic point-of-care test for Chlamydia trachomatis. Key findings include:
1) Participants were willing to accept longer test times and slightly higher instrument costs to preserve attributes like lower test cost, vaginal sample type, and processing multiple samples per batch.
2) Analysis of survey data identified where participants were willing to compromise on attributes and where they were unwilling.
3) The methodology provides a way to understand user needs and tradeoffs to help bridge the gap between need and realization of new diagnostic technologies.
Standardizing Care and Increasing Efficiency in an Atrial Fibrillation ProgramJose Osorio
As the number of patients with afib continue to increase in the US, there is a growing need for Afib ablations. With a limited number of EP labs and doctors, each hospital will have to find safe ways to increase their number of procedures to meet the demand.
Our experience shows that by standardizing care and following guidelines and internal protocols, AF ablation programs can increase safety and efficacy while improving efficiency.
ECO10 - Measuring the true pathway of innovation in the NHSInnovation Agency
The document discusses the introduction and clinical evidence for the UroLift system, a minimally invasive treatment for benign prostatic hyperplasia (BPH). It summarizes the clinical trials demonstrating UroLift's rapid and durable relief of BPH symptoms with minimal side effects. It also outlines UroLift's journey to approval and reimbursement in the UK, including a positive NICE recommendation and being granted an Innovation Technology Tariff to facilitate adoption in the NHS. UroLift is positioned as a cost-effective alternative to traditional BPH surgeries that allows for quicker recovery and preservation of sexual function.
Case presentation (lab analytical quality assurance problem )Rania Elsharkawy
This case presentation describes a 64-year-old female patient who visited the laboratory for requested tests and encountered discrepant results between two laboratories for her intact parathyroid hormone (iPTH) level. The receptionist failed to record the patient's drug history, including her use of biotin supplements. After initial testing found low iPTH, total calcium, and alkaline phosphatase levels consistent with adynamic bone disease, a second laboratory found a significantly higher iPTH level. The laboratory investigated potential pre-analytical, analytical, and post-analytical errors and determined biotin interference affected the iPTH assay, providing a falsely low result. The case highlights the importance of thorough history taking including medication
The document discusses standard laboratory practices and standard operating procedures (SOPs) developed by the Health Protection Agency (HPA) in the UK. It provides an overview of the HPA's Standards and Evaluations units, which develop SOPs for clinical microbiology laboratories. It also discusses feedback from a survey of laboratories on the SOP for investigating genital tract specimens, including which aspects they found useful and suggestions for improvement. The talk concludes with plans to develop a new SOP for screening group B streptococcus from genital swabs.
Biological variation as an uncertainty componentGH Yeoh
To assist the clinical interpretation of a test result, there is a necessity to have an additional non-analytical component in the overall estimation of UM, namely the biological variation.
The document discusses point-of-care testing (POCT) in outpatient departments. It defines POCT as medical diagnostic testing performed close to patients and outside clinical laboratories. Key benefits of POCT include faster results and feedback to patients, enabling timely treatment. Specific POCT tests mentioned include complete blood count, blood gases, glucose, CRP, lipid profiles, and urine tests. Challenges of POCT include ensuring quality and appropriate use. The document argues POCT can help reduce unnecessary antibiotic prescription by providing rapid white blood cell counts for pediatric patients.
This document summarizes the history and types of surgical drainage. It discusses active drains that use suction versus passive drains that rely on gravity. The evidence for and against drain use in different surgical procedures is examined through a review of literature including randomized controlled trials and meta-analyses. For many GI surgeries like cholecystectomy and appendectomy, evidence shows drains do not provide benefits and may increase complications, so drainage is not recommended. Further research is still needed for some procedures.
Best Practices for a Data-driven Approach to Test UtilizationViewics
Would you like to learn how data-driven interventions can improve laboratory test utilization in your organization? Would you like to hear about the impact that leading hospitals/health systems and managed care organizations have made through these interventions?
If so, you might be interested in this presentation by utilization management expert Dr. Michael Astion, Medical Director at the Department of Laboratories at Seattle Children’s Hospital and Clinical Professor of Laboratory Medicine at the University of Washington.
In this presentation, Dr. Astion discusses the current state of the misuse of laboratory testing in the United States and some of the interventions that are being implemented to improve it. He covers a number of common areas of unnecessary testing — from pure abuse to tests that could be useful but are ordered inappropriately.
You'll learn about:
• Two areas of laboratory testing where misordering of tests occur frequently
• Three interventions to improve the value of testing for patients
• The role of genetic counselors and other laboratory professionals in improving lab test ordering
• The national endeavor known as PLUGS, the Pediatric Laboratory Utilization Guidance Service
This review aimed to evaluate interventions for managing external root resorption in permanent teeth. No randomized controlled trials meeting the inclusion criteria were identified. External root resorption has various classifications and causes, including trauma, orthodontic treatment, and pressure from adjacent teeth. Potential treatments include root canal treatment, surgery to remove resorbed tissue, splinting mobile teeth, and extraction. However, there is no consensus on managing different forms of external root resorption due to a lack of high-quality evidence. Future research is needed in the form of randomized controlled trials.
This document provides guidelines for sterility testing of therapeutic goods in Australia. It discusses regulatory aspects and the rationale for sterility testing. It provides guidance on sampling lots for testing, including minimum numbers of items to sample based on batch size. It also lists the minimum quantities of products that should be tested from each container. The guidelines aim to provide a rigorous yet efficient approach to sterility testing to ensure therapeutic goods meet standards for quality and safety.
This document provides an overview of clinical trial design. It discusses the typical phases of clinical trials including:
- Phase I which focuses on safety and dose escalation
- Phase II which screens for therapeutic activity and further evaluates toxicity
- Phase III which uses a proper control group to further evaluate efficacy and monitors long-term safety
It also describes various study designs including randomized controlled trials, parallel designs, cross-over designs, and cohort studies. Key aspects of each design like advantages, disadvantages, and implementation are covered. The document provides a comprehensive yet concise primer on clinical trial methodology.
Environmental scans versus horizon scans; systematic reviews versus rapid rev...Kimberly Yang
Talk comparing environmental scans with horizon scans, systematic reviews, rapid reviews, and core outcome sets, presented to Center for Medical Technology Policy (CMTP) staff by Kimberly F. Yang on September 28, 2015
Biochemical tests in clinical medicine lect1MUDASSAR ANWER
This document discusses biochemical tests in clinical medicine. It covers topics such as the role of clinical biochemistry laboratories in disease diagnosis and treatment monitoring, common analyses performed, and diseases investigated using these tests. It also addresses the uses of biochemical tests in diagnosis, screening, prognosis, and treatment, as well as factors that can affect test results and their interpretation.
summary report of inspections of clinical trials conducted from April 2004 to...mahmoudnasseri
This document summarizes Health Canada inspections of clinical trials conducted from 2004 to 2011. During this period, 329 inspections found 3148 observations of non-compliance, mostly related to quality systems/procedures and record keeping. 92% of inspections were rated compliant and 8% non-compliant. Common deficiencies included lack of standard operating procedures, inadequate documentation and personnel training. The report aims to increase awareness of regulatory requirements and improve compliance for protecting clinical trial participants.
Effects of Intralesional Triamcinalone injection following Internal Urethroto...iosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
This document discusses predicting patient risk of acquiring Klebsiella pneumoniae carbapenemase producing organisms (KCPO) and linking environmental exposure to patient acquisition. It describes developing a patient risk model using a case-control approach and clinical and demographic data. A naïve Bayesian model was built and validated, showing an AUC of 0.746. It then analyzes the impact of positive room environments on patient infection using a treatment effects model, controlling for patient risk and length of stay. The results show room positivity is significantly associated with acquisition of infection, with an odds ratio of 22.25. Ultimately, interventions like hopper covers and heater traps reduced environmental transmission.
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
This presentation is aimed at presenting the issues associated with subgroup analyses in clinical trials: the different types of subgroup analyses and the statistical issues associated with the conduct of subgroup analyses.
Semen analysis as per WHO and clinical implicationsSandro Esteves
This document discusses semen analysis, new WHO reference values from 2010, and implications for clinical management. Key points include:
- Semen analysis provides biomarkers to predict fertility potential but has limitations on its own.
- The 2010 WHO reference values were derived from a meta-analysis of recent father studies and established new lower cut-off limits.
- The new WHO values resulted in many patients being reclassified from abnormal to normal ranges, especially for morphology, and impacted referral patterns, treatment recommendations, and access to ART.
- A comprehensive male fertility evaluation requires more than just a semen analysis and should include history, physical exam, hormones, and advanced sperm testing to properly diagnose and manage cases.
Quality Improvement in an AF Ablation ProgramJose Osorio
Atrial fibrillation ablation is an important treatment options for patients with AF. The number of AF ablations continue to rise annually but there is a limited number of Electrophysiology Laboratories and doctors. With the increasing prevalence of Afib, many institutions are finding bottlenecks with the increase volume.
We propose that a quality improvement initiative is the ideal way to improve efficiency, outcomes and safety of AF ablations with the end results being more patients treated with good results.
Driving Point of Care Technology Development: Integrated Approach to Consensu...CFTCC
The WALEX process combines facilitated discussion and discrete choice experiments to define the attributes of a realistic point-of-care test for Chlamydia trachomatis. Key findings include:
1) Participants were willing to accept longer test times and slightly higher instrument costs to preserve attributes like lower test cost, vaginal sample type, and processing multiple samples per batch.
2) Analysis of survey data identified where participants were willing to compromise on attributes and where they were unwilling.
3) The methodology provides a way to understand user needs and tradeoffs to help bridge the gap between need and realization of new diagnostic technologies.
Standardizing Care and Increasing Efficiency in an Atrial Fibrillation ProgramJose Osorio
As the number of patients with afib continue to increase in the US, there is a growing need for Afib ablations. With a limited number of EP labs and doctors, each hospital will have to find safe ways to increase their number of procedures to meet the demand.
Our experience shows that by standardizing care and following guidelines and internal protocols, AF ablation programs can increase safety and efficacy while improving efficiency.
ECO10 - Measuring the true pathway of innovation in the NHSInnovation Agency
The document discusses the introduction and clinical evidence for the UroLift system, a minimally invasive treatment for benign prostatic hyperplasia (BPH). It summarizes the clinical trials demonstrating UroLift's rapid and durable relief of BPH symptoms with minimal side effects. It also outlines UroLift's journey to approval and reimbursement in the UK, including a positive NICE recommendation and being granted an Innovation Technology Tariff to facilitate adoption in the NHS. UroLift is positioned as a cost-effective alternative to traditional BPH surgeries that allows for quicker recovery and preservation of sexual function.
Case presentation (lab analytical quality assurance problem )Rania Elsharkawy
This case presentation describes a 64-year-old female patient who visited the laboratory for requested tests and encountered discrepant results between two laboratories for her intact parathyroid hormone (iPTH) level. The receptionist failed to record the patient's drug history, including her use of biotin supplements. After initial testing found low iPTH, total calcium, and alkaline phosphatase levels consistent with adynamic bone disease, a second laboratory found a significantly higher iPTH level. The laboratory investigated potential pre-analytical, analytical, and post-analytical errors and determined biotin interference affected the iPTH assay, providing a falsely low result. The case highlights the importance of thorough history taking including medication
The document discusses standard laboratory practices and standard operating procedures (SOPs) developed by the Health Protection Agency (HPA) in the UK. It provides an overview of the HPA's Standards and Evaluations units, which develop SOPs for clinical microbiology laboratories. It also discusses feedback from a survey of laboratories on the SOP for investigating genital tract specimens, including which aspects they found useful and suggestions for improvement. The talk concludes with plans to develop a new SOP for screening group B streptococcus from genital swabs.
Biological variation as an uncertainty componentGH Yeoh
To assist the clinical interpretation of a test result, there is a necessity to have an additional non-analytical component in the overall estimation of UM, namely the biological variation.
The document discusses point-of-care testing (POCT) in outpatient departments. It defines POCT as medical diagnostic testing performed close to patients and outside clinical laboratories. Key benefits of POCT include faster results and feedback to patients, enabling timely treatment. Specific POCT tests mentioned include complete blood count, blood gases, glucose, CRP, lipid profiles, and urine tests. Challenges of POCT include ensuring quality and appropriate use. The document argues POCT can help reduce unnecessary antibiotic prescription by providing rapid white blood cell counts for pediatric patients.
This document summarizes the history and types of surgical drainage. It discusses active drains that use suction versus passive drains that rely on gravity. The evidence for and against drain use in different surgical procedures is examined through a review of literature including randomized controlled trials and meta-analyses. For many GI surgeries like cholecystectomy and appendectomy, evidence shows drains do not provide benefits and may increase complications, so drainage is not recommended. Further research is still needed for some procedures.
Best Practices for a Data-driven Approach to Test UtilizationViewics
Would you like to learn how data-driven interventions can improve laboratory test utilization in your organization? Would you like to hear about the impact that leading hospitals/health systems and managed care organizations have made through these interventions?
If so, you might be interested in this presentation by utilization management expert Dr. Michael Astion, Medical Director at the Department of Laboratories at Seattle Children’s Hospital and Clinical Professor of Laboratory Medicine at the University of Washington.
In this presentation, Dr. Astion discusses the current state of the misuse of laboratory testing in the United States and some of the interventions that are being implemented to improve it. He covers a number of common areas of unnecessary testing — from pure abuse to tests that could be useful but are ordered inappropriately.
You'll learn about:
• Two areas of laboratory testing where misordering of tests occur frequently
• Three interventions to improve the value of testing for patients
• The role of genetic counselors and other laboratory professionals in improving lab test ordering
• The national endeavor known as PLUGS, the Pediatric Laboratory Utilization Guidance Service
the role of Cochrane collaboration and specifically the menstrual disorder & subfertility group is illustrated . simple explanation how to use cochrane reviews is done.
This document discusses quality control in histopathology. It defines key terms like quality control, quality assurance, and total quality management. It outlines the pre-analytical, analytical and post-analytical phases of quality control and highlights variables that can affect quality in each phase like personnel training, equipment, and interpretation of results. It provides recommendations for achieving quality control through standardized procedures, monitoring turnaround times, participation in proficiency testing, and review of reports. The goal is to generate accurate histopathology reports and enable easy retrieval if needed.
This systematic review analyzed 37 studies on quality control practices in processing respiratory specimens in microbiology laboratories. The studies were published between 2010-2023, with most (76%) in the last 5 years. Various study designs were used, including observational studies (57%), systematic reviews (22%), and expert opinions (14%). Common specimen types studied were sputum (43%) and nasopharyngeal swabs (30%). While processing and testing methods varied, most studies (78%) recommended quality control measures such as use of standardized protocols, regular performance monitoring, participation in external assurance programs, and staff training. In conclusion, the review highlighted the importance of quality control to ensure reliable and valid laboratory results for respiratory infections.
Novel treatments to trigger final follicular maturation and luteal phase supportSandro Esteves
This document summarizes novel strategies for triggering final follicular maturation and supporting the luteal phase in fertility treatments. It discusses evaluating the quality of trigger and luteal phase support methods based on indicators of safety, effectiveness, and patient-centeredness. Specific strategies used at Androfert clinic are presented, including individualizing triggers and support according to patient risk factors. Recombinant hCG is shown to have advantages over urinary hCG in terms of effectiveness, safety, and patient preferences. GnRH agonist triggering avoids risk of ovarian hyperstimulation syndrome but needs additional luteal phase support.
The study compared the reliability and diagnostic accuracy of routine NHS laboratories and a research laboratory in diagnosing urinary tract infections (UTIs) in young children. The research laboratory showed substantially better agreement with predefined signs/symptoms of UTIs and with a clean-catch urine sample method. The NHS laboratories appeared to overdiagnose UTIs from nappy pad samples due to failure to distinguish contamination. The implications are that NHS laboratories may benefit from adopting the research laboratory's standardized methods, and clinicians should focus on obtaining higher-quality clean-catch urine samples for improved UTI diagnosis in young children.
The document discusses interpreting semen analysis results and the implications of the 2010 WHO reference values. It summarizes the WHO reference values over time and how the 2010 values changed the parameters and reference populations. The new 2010 values result in many patients being reclassified and can impact referral for treatment, treatment recommendations, and eligibility for assisted reproduction. A comprehensive evaluation is necessary and semen analysis alone should not determine diagnosis or treatment.
Clinician Satisfaction Before and After Transition from a Basic to a Comprehe...Allison McCoy
Healthcare organizations are transitioning from basic to comprehensive electronic health records (EHRs) to meet Meaningful Use requirements and improve patient safety. Yet, full adoption of EHRs is lagging and may be linked to clinician dissatisfaction. In depth assessment of satisfaction before, during, and after EHR transition is rarely done. Using an adapted published tool to assess adoption and satisfaction with EHRs, we surveyed clinicians at a large, non-profit academic medical center before (baseline) and 6-12 months (short-term follow-up) and 12-24 months (long-term follow-up) after transition from a basic, locally-developed to a comprehensive, commercial EHR. Satisfaction with the EHR (overall and by component) was captured at each interval. Overall satisfaction was highest at baseline (85%), lowest at short-term follow-up (66%), and increasing at long-term follow-up (79%). This trend was similar for satisfaction with EHR components designed to improve patient safety including clinical decision support, patient communication, health information exchange, and system reliability. Conversely, at baseline, short-term and long-term follow-up, perceptions of productivity, ability to provide better care with the EHR, and satisfaction with available resources, were lower at both short- and long-term follow-up compared to baseline. Persistent dissatisfaction with productivity and resources was identified. Addressing determinants of dissatisfaction may increase full adoption of EHRs. Further investigation in larger populations is warranted.
Novel Concepts in Male Infertility: Clinical and Laboratory AspectsSandro Esteves
This document summarizes a presentation on novel concepts in male infertility. It discusses updates to WHO reference values for semen analysis and the importance of testing for sperm DNA fragmentation. Interventions for infertile men undergoing ART like varicocele repair and oral antioxidants are reviewed. Diagnosis and management of azoospermia, including the role of gonadotropin therapy for hypo-hypo, is discussed. Challenges in counseling men with spermatogenic failure are also addressed.
Similar to Adherence to WHO 2010 Recommendations with regard to Semen Analysis Reports in the Laboratories if West Bengal (20)
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Dr Sujoy Dasgupta was invited to deliver a lecture on "Male Infertility, Antioxidants and Beyond" on 3 February in Yuvacon 2024 organized by the Bengal Obstetric and Gynaecological Society (BOGS). The session was supported by UNS.
"Radical excision of DIE in subferile women with deep infiltrating endometrio...Sujoy Dasgupta
Dr Sujoy Dasgupta participated in an invited debate FOR the motion "Radical excision of DIE in subferile women with deep infiltrating endometriosis is not recommended" in ENDOGYN 2024, organized by the IAGE (Indian Association of Gynaecological Endoscopists) and the BOGS (Bengal Obstetric and Gynaecological Society) on 10 February 2024.
Adenomyosis or Fibroid- making right diagnosisSujoy Dasgupta
Invited lecture by Dr Sujoy Dasgupta in the Ultrasound Workshop of the Annual National Conference of Indian Association of Gynaecological Endoscopists (IAGE) held on 15 March 2024 at the Taj Ganges, Varanasi
Invited lecture by Dr Sujoy Dasgupta on "Azoospermia - Evaluation and Management" in a CME on "Standardising Male Factor Evaluation" organised by Indian Fertility Society (IFS) on 20 January 2024.
Are we giving much importance to AMH in infertility practice?Sujoy Dasgupta
Dr Sujoy Dasgupta delivered "Kamini Rao Oration" on "Are we giving much importance to AMH in infertility practice?" in East Zone Yuva FOGSI Conference organized by Imphal Obstetric and Gynaecological Society (IOGS) on 24 December, 2023
Male Infertility-How a Gynaecologist can Manage?Sujoy Dasgupta
Dr Sujoy dasgupta delivered an invited lecture on "Male Infertility-How a Gynaecologist can Manage?" in a CME on "New Frontiers in Infertility" organized by Genome Fertility Centre and Bhagirathi Neotia Woman and Child Care Centre, Kolkata held on 15 December 2023
Endometriosis and Subfertility, Primium non nocereSujoy Dasgupta
Dr Sujoy dasgupta and Dr Arun Madhab Barua were invited to moderate a panel discussion on "Endometriosis and Subfertility, Primium non nocere" in the International Congress on Endometriosis (ICE) on 10 December 2023 at Dhana Dhanya Auditorium, Kolkata
Dr Sujoy Dasgupta delivered an invited talk on "Embryo Transfer" in "Ultrasound Workshop" on 8 December 2023 at Milan, 2023, the conference of all the Obstetric and Gynaecological Societies of West Bengal. This conference was organized by Kalyani Obstetric and Gynaecological Society (KOGS).
Rational Investigations and Management of Male InfertilitySujoy Dasgupta
Dr Sujoy Dasgupta delivered an invited lecture in the annual conference of WMOGS (West Midnapore Obstetric and Gynaecological Society) held on 16 September, 2023
Endometriosis and Subfertility - What to do?Sujoy Dasgupta
Lecture delivered by Dr Sujoy Dasgupta in IPCON 2823, the Mid term conference of ISOPARB (Indian Society of Perinatology and Reproductive Biology) held at Kolkata on 10 September
IVF- How it changed the perspective of Male InfertilitySujoy Dasgupta
This document discusses male infertility and the role of IVF in changing perspectives on male infertility. It provides details on semen analysis reports for multiple patients and discusses what the results indicate about the severity of male factor infertility and next steps. It also discusses evaluating and treating various causes of male infertility like varicocele, cryptorchidism, hormonal abnormalities, and genetic factors. The importance of a detailed history and physical examination is emphasized to properly diagnose the underlying issues.
Male Infertility- How Gynaecologists can manage?Sujoy Dasgupta
Dr Sujoy Dasgupta delivered an invited lecture in a CME organised by JB Pharma with the support from West Midnapore Obst and Gynae Society and Genome Fertility Centre held at Medinipur on 22 July, 2023.
Role of Multivitamins & Antioxidants in Managing Male Infertility Sujoy Dasgupta
Dr Sujoy Dasgupta was invited to deliver a talk on "Role of Multivitamins & Antioxidants in Managing Male Infertility " in a CME organized by Agartala Obstetric and Gynaecological Society and ArEx Laboratory held at Agartala on 8 July 2023
Panel discussion moderated by Dr Sujoy Dasgupta and Dr Sudip Basu on "Troubleshooting in Male Subfertility" in the Andrology Workshop organized by Special Interest Group (SIG) Andrology and Indian Fertility Society (IFS) West Bengal Chapter held on 11 June 2023 at Kolkata
Fertility Management: Synergy between Endoscopists and Fertility SpecialistsSujoy Dasgupta
Dr Sujoy Dasgupta was invited to moderate a panel discussion on "Fertility Management: Synergy between Endoscopists and Fertility Specialists " in a CME by Torrent held on 27 May 2023.
ESHRE Guideline on Recurrent Pregnancy Loss (RPL)Sujoy Dasgupta
Dr Sujoy Dasgupta invited to deliver a lecture on "RPL- ESHRE Guideline" in the Annual Conference of RCOG (Royal College of Obstetricians and Gynaecologists) IRC (International Representative Committee) India East held on 20-21 May, 2023
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
Travel Clinic Cardiff: Health Advice for International TravelersNX Healthcare
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Adherence to WHO 2010 Recommendations with regard to Semen Analysis Reports in the Laboratories if West Bengal
1. Adherence to WHO 2010
Recommendations with regard to
Semen Analysis Reports in the
Laboratories of West Bengal
Sujoy Dasgupta
MBBS MS DNB MRCOG
Consultant, Reproductive Medicine, Genome Fertility Centre, Kolkata
2. Semen Analysis
• An integral part of evaluation of a subfertile male.
• Reflects the genital tract health of a man three months prior to
collection
3. Variation of Semen Analysis Results
• Significant day to day variation
• Inter-Laboratory Variation
4. Standards of Semen Analysis
• Standard reference values are necessary, but how they are developed or
defined varies.
• The World Health Organization (WHO) has set specific recommendations
for reporting sperm parameters- 1980, 1987, 1992, 1999
• The data were derived from imprecisely defined reference populations
and obtained from laboratories with unknown comparability with
respect to analytical methodologies.
5. Esteves S C. Clinical relevance of routine semen analysis and controversies surrounding the 2010 World
Health Organization criteria for semen examination. Int Braz J Urol. 2014; 40: 443-53
6. WHO 2010 (5th Edition)
• Based on parameters in a large group of fertile men along with defined
confidence intervals from recent fathers with known time-to-pregnancy
(TTP).
• These reference values were based on limited data to define normal fertility,
along with consensus determination.
• The WHO does not consider the values set as true reference values but
recommends or suggests acceptable levels.
• The reason for this vagueness is partly that values may vary from region to
region.
• Laboratories rarely, if ever, perform these tests to determine regional levels,
owing to the time and cost.
• The WHO provides such foundation for parameters.
7. Cooper TG et al. World Health Organization reference values for human semen
characteristics. Hum Reprod Update. 2010; Vol.16: 3, 231–245
8. • Accuracy of the actual testing is of utmost importance and technician
dependent
• The parameters relative to the reference values are one of the first steps
that set the basis for referrals to specialists, investigation of
underlying causes, and determination of treatment options.
• Careful understanding of reference values determination should be
considered.
Reference Values
9. That’s Why
• Western Studies found the lack of uniformity among the laboratories in
assessing and reporting semen samples (Mainly WHO 1999, few studies WHO
2010)
• Our study looked into the adherence of reporting of semen analysis with the
WHO 2010 guidelines.
10. To determine adherence to WHO 2010
Standards while reporting Semen Analysis
Results
To compare the reference values quoted on
these reports with those set by the WHO 2010
Guideline
To compare the reporting of ART laboratories
and Non-ART laboratories with respect to
Semen Analysis
*ART- Assisted Reproductive Technology
12. Study Design
Observational Study
Study Subject
Semen Analysis reports obtained from January 2018 to June 2018
obtained from laboratories of West Bengal, India
1. Individual patients presented to our Fertility Clinic
2. Reports sent by the patients online to their treating doctors
3. Directly from the laboratory
13. Exclusion Criteria
• Reports done before 2012
• Reports showing Azoospermia/ Cryptozoospermia/ Severe
Oligozoopermia (where details of motility/ morphology analysis
not possible)
Approved by Institutional Ethics Committee
14. Study Methodology
Written Informed Consent from all the participants
Reports were anonymized
Details mentioned in the report were put in the Excel Sheet
Reports were compared against standards and references laid by WHO, 2010
15. If did not match with WHO 2010 standards or references
Search was made to determine
whether the reports matched with previous versions of WHO Semen Analysis Standards
(1999, 1992, 1987 and 1980)
Laboratories were divided in two Categories
1. ART Laboratories-
Laboratories attached with ART clinics
2. Non-ART Laboratories
Local/ regional pathology/ hospital laboratories
16. Results were expressed in numbers and proportions (%)
Results between ART and Non-ART laboratories were compared by
Z Score for 2 Population Proportions
p value <0.05 considered as significant
18. Number of Semen
Reports obtained
Individual patients presented to Fertility Clinics and/
or Gynaecologists
196
234Reports sent by the patients online to their treating
doctors
33
Directly from the laboratory 5
Excluded 23
Final Analysis N= 211
Number of Laboratory-Reports Obtained
19. N= 15
(7. 109%)
N= 196
(92.891%)
Total Number of Laboratories (N = 211)
ART Lab
Non-ART Lab
21. Collection Details
• There is some evidence that the quality of semen specimens varies depending on how the
ejaculate is produced.
• Ejaculates produced by masturbation and collected into containers in a room near the
laboratory can be of lower quality than those recovered from non-spermicidal condoms used
during intercourse at home (Zavos & Goodpasture, 1989).
• The results of laboratory measurements of semen quality will depend on:
1. Whether a complete sample is collected. During ejaculation the first semen fractions
voided are mainly sperm-rich prostatic fluids, whereas later fractions are dominated by
seminal vesicular fluid (Björndahl & Kvist, 2003).
2. The time since the last sexual activity
3. The penultimate abstinence period.
22. WHO Laboratory Manual for the Examination and Processing of Human Semen FIFTH EDITION. 2010
24. Abstinence Period (AP)
Mentions AP Proportion of those who mention P value
ART Lab (n= 15) 15 100% 0.25014
(Not
significant)
Non ART Lab (n= 196) 180 91.836%
Total (n= 211) 195 92.417%
25. Collection Time (CT) and Examination Time (ET)
Total (n = 211)
Mentions CT 103
Proportions mentioning CT 48.815%
Mentions ET 52
Proportions mentioning ET 24.645%
Mentions both CT and ET 50
Proportions mentioning both CT and ET 23.697%
Mentions neither CT nor ET 106
Proportions of mentioning neither CT nor ET 50.237%
26. Collection Time (CT) and Examination Time (ET)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions CT 11 92 103
Proportions mentioning CT 73.333% 46.939% 48.815%
P value 0.04884 (Significant)
Mentions ET 52
Proportions mentioning ET 24.645%
Mentions both CT and ET 50
Proportions mentioning both CT and ET 23.697%
Mentions neither CT nor ET 106
Proportions of mentioning neither CT nor ET 50.237%
27. Collection Time (CT) and Examination Time (ET)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions CT 11 92 103
Proportions mentioning CT 73.333% 46.939% 48.815%
P value 0.04884 (Significant)
Mentions ET 5 47 52
Proportions mentioning ET 33.333% 23.979% 24.645%
P value 0.41794 (Not Significant)
Mentions both CT and ET 50
Proportions mentioning both CT and ET 23.697%
Mentions neither CT nor ET 106
Proportions of mentioning neither CT nor ET 50.237%
28. Collection Time (CT) and Examination Time (ET)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions CT 11 92 103
Proportions mentioning CT 73.333% 46.939% 48.815%
P value 0.04884 (Significant)
Mentions ET 5 47 52
Proportions mentioning ET 33.333% 23.979% 24.645%
P value 0.41794 (Not Significant)
Mentions both CT and ET 5 45 50
Proportions mentioning both CT and ET 33.333% 22.959% 23.697%
P value 0.36282 (Not Significant)
Mentions neither CT nor ET 106
Proportions of mentioning neither CT nor ET 50.237%
29. Collection Time (CT) and Examination Time (ET)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions CT 11 92 103
Proportions mentioning CT 73.333% 46.939% 48.815%
P value 0.04884 (Significant)
Mentions ET 5 47 52
Proportions mentioning ET 33.333% 23.979% 24.645%
P value 0.41794 (Not Significant)
Mentions both CT and ET 5 45 50
Proportions mentioning both CT and ET 33.333% 22.959% 23.697%
P value 0.36282 (Not Significant)
Mentions neither CT nor ET 4 102 106
Proportions of mentioning neither CT nor ET 2.667% 52.041% 50.237%
P value 0.05876 (Not Significant)
30. Details of Collection
Total (n = 211)
Mentions Site of Collection 104
Proportions mentioning Site 49.289%
Mentions Completeness of Collection 102
Proportions mentioning Completeness 48.341%
Mentions Method of Collection 65
Proportions mentioning Method 30.806%
31. Details of Collection
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions Site of Collection 12 92 104
Proportions mentioning Site 80.000% 46.939% 49.289%
P value 0.01352 (Significant)
Mentions Completeness of Collection 102
Proportions mentioning Completeness 48.341%
Mentions Method of Collection 65
Proportions mentioning Method 30.806%
32. Details of Collection
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions Site of Collection 12 92 104
Proportions mentioning Site 80.000% 46.939% 49.289%
P value 0.01352 (Significant)
Mentions Completeness of Collection 12 90 102
Proportions mentioning Completeness 80.000% 45.918% 48.341%
P value 0.01078 (Significant)
Mentions Method of Collection 65
Proportions mentioning Method 30.806%
33. Details of Collection
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions Site of Collection 12 92 104
Proportions mentioning Site 80.000% 46.939% 49.289%
P value 0.01352 (Significant)
Mentions Completeness of Collection 12 90 102
Proportions mentioning Completeness 80.000% 45.918% 48.341%
P value 0.01078 (Significant)
Mentions Method of Collection 5 60 65
Proportions mentioning Method 33.333% 30.612% 30.806%
P value 0.82588 (Not Significant)
34. WHO Laboratory Manual for the Examination and Processing of Human Semen FIFTH EDITION. 2010
Liquefaction Time (LT)
35. Liquefaction Time (LT)
Mentions LT No Mention Proportion of those who mention
ART Lab
(n= 15)
1- No mention
1- Satisfactory (?)
Non ART Lab
(n= 196)
38- No mention
3- Normal (1- WHO 2010
Ref)
1- Satisfactory (WHO 2010
Ref)
2- Liquefied (?)
1- Complete (WHO 2010
Ref)
1- Positive (?)
Total (n= 211) 163 48 77.251%
36. Liquefaction Time (LT)
Mentions LT No Mention Proportion of those who mention P value
ART Lab
(n= 15)
13 1- No mention
1- Satisfactory (?)
86.667% 0.36812
(Not
Significant)
Non ART Lab
(n= 196)
150 38- No mention
3- Normal (1- WHO 2010
Ref)
1- Satisfactory (WHO 2010
Ref)
2- Liquefied (?)
1- Complete (WHO 2010
Ref)
1- Positive (?)
76.531%
Total (n= 211) 163 48 77.251%
37. Reference value of Liquefaction Time
WHO 2010/ 1999/ 1992 (<60
Min)
Wrong
Reference
No mention
of any
reference
Proportion of
those using WHO
2010Mentions
value
Only WHO
2010
Total (n= 211) 35 3 10 163 38/ 211= 18.009%
38. Reference value of Liquefaction Time
WHO 2010/ 1999/ 1992 (<60
Min)
Wrong
Reference
No mention
of any
reference
Proportion of
those using WHO
2010
P value
Mentions
value
Only WHO
2010
ART Lab
(n= 15)
4 1 10 4/ 15= 26.667% 0.36282
(Not
Significant)
Non ART Lab
(n= 196)
31 3 9 153 34/ 196= 17.347%
Total (n= 211) 35 3 10 163 38/ 211= 18.009%
39. WHO Laboratory Manual for the Examination and Processing of Human Semen FIFTH EDITION. 2010
Viscosity
40. Viscosity
Mentions Viscosity No Mention Proportions of those who
mention
ART Lab (n= 15) Normal- 11
Non ART Lab
(n= 196)
Normal 58
Good 2
Viscous/ Viscid 31
High/ Increased/ Thick- 13
Moderate/ medium-7
Less/ low/ Thin/ Slight/ Mild- 21
Liquid- 1
Mucoid- 4
Plus 2
Poor 1
Opaque 1
Positive 1
Semen- 1
Semiviscous 1
Total (n= 211) 156 55 156/ 211 = 73.934%
41. Viscosity
Mentions Viscosity No Mention Proportions of those who
mention
P value
ART Lab (n= 15) 11 Normal- 11 4 11/ 15= 73.333% 0.56192
(Not
Significant)
Non ART Lab
(n= 196)
145 Normal 58
Good 2
Viscous/ Viscid 31
High/ Increased/ Thick- 13
Moderate/ medium-7
Less/ low/ Thin/ Slight/ Mild- 21
Liquid- 1
Mucoid- 4
Plus 2
Poor 1
Opaque 1
Positive 1
Semen- 1
Semiviscous 1
51 145/ 196= 73.979%
Total (n= 211) 156 55 156/ 211 = 73.934%
42. Reference value of Viscosity
WHO 2010/ 1999/
1992 (Normal)
Other Reference No mention of
any reference
Proportion of those
using WHO 2010
Total (n= 211) 30 1 180 14.218%
43. Reference value of Viscosity
WHO 2010/ 1999/
1992 (Normal)
Other Reference No mention of
any reference
Proportion of those
using WHO 2010
P value
ART Lab
(n= 15)
3 12 20.000% 0.50286
(Not
Significant)
Non ART Lab
(n= 196)
27 1 (“Normally +”) 168 13.775%
Total (n= 211) 30 1 180 14.218%
46. Appearance
Mentions No Mention Proportion of those who mention P value
ART Lab
(n= 15)
14 1 93.333% 0.88866
(Not Significant)Non ART Lab
(n= 196)
181 15 92.347%
Total (n= 211) 195 16 92.417%
49. There are currently few reference values for the pH of semen from
fertile men.
Pending more data, this manual retains the consensus value of 7.2 as a
lower threshold value.
Reaction
WHO Laboratory Manual for the Examination and Processing of Human Semen FIFTH EDITION. 2010
50. Reference value of pH
WHO Other
References
No mention of
any reference
Proportion of
those using WHO
2010
2010/ 1999/ 1992
(7.2-8.0)
Only mentions
WHO 2010
Total (n= 211) 43 4 3 “Alkaline” 161 20.379%
51. Reference value of pH
WHO Other
References
No mention of
any reference
Proportion of
those using WHO
2010
P value
2010/ 1999/ 1992
(7.2-8.0)
Only mentions
WHO 2010
ART Lab
(n= 15)
5 1 9 33.333% 0.19706
(Not
Significant)
Non ART Lab
(n= 196)
38 3 3- “Alkaline” 152 19.388%
Total (n= 211) 43 4 3 “Alkaline” 161 20.379%
52. Volume
Mentions Vol No Mention Proportion of those who
mention
Total (n= 211) 210 1 99.526%
53. Volume
Mentions Vol No Mention Proportion of those who
mention
P value
ART Lab (n= 15) 15 0 100% 0.77948
(Not
Significant)
Non ART Lab (n= 196) 195 1 (Adequate- ?)
Not calculable
99.489%
Total (n= 211) 210 1 99.526%
54. Reference value of Volume
WHO 2010 Ref Other WHO Ref No mention of
any reference
Proportion of
those using WHO
2010
Mentions
value (1.5 ml)
Only
“WHO
2010”
1999/ 1992/ 1987
(≥ 2 ml)
Total (n= 211) 30 4 23 154 16.114%
55. Reference value of Volume
WHO 2010 Ref Other WHO Ref No mention of
any reference
Proportion of
those using WHO
2010
P value
Mentions
value (1.5 ml)
Only
“WHO
2010”
1999/ 1992/ 1987
(≥ 2 ml)
ART Lab
(n= 15)
5 1 1 8 40.00% 0.00906
(Significant)Non ART Lab
(n= 196)
25 3 22 146 14.286%
Total (n= 211) 30 4 23 154 16.114%
58. Agglutination
Mentions Agglutination No Mention Proportion of those who
mention
Nil 5
Present 5
Nil 17
Grade II- 2
Grade I- 3
Clump+ 1
Present 14
Total (n= 211) 47 164 47/ 211 = 22.275%
59. Agglutination
Mentions Agglutination No Mention Proportion of those who
mention
P value
ART Lab
(n= 15)
10 Nil 5
Present 5
5 10/ 15= 66.667% 0
(Significant)
Non ART Lab
(n= 196)
37 Nil 17
Grade II- 2
Grade I- 3
Clump+ 1
Present 14
159 37/ 196= 18.878%
Total (n= 211) 47 164 47/ 211 = 22.275%
60. Reference value of Agglutination
WHO 2010 No mention of
any reference
Proportion of
those using WHO
2010
Mentions
(Nil)
Only mentions
WHO 2010
Total (n= 211) 6 4 201 10/ 211= 4.739%
61. Reference value of Agglutination
WHO 2010 No mention of
any reference
Proportion of
those using WHO
2010
P value
Mentions
(Nil)
Only mentions
WHO 2010
ART Lab
(n= 15)
1 1 13 2/ 15= 13.333% 0.1031
(Not Significant)Non ART Lab
(n= 196)
5 3 188 8/ 196= 4.082%
Total (n= 211) 6 4 201 10/ 211= 4.739%
62. • Total number of spermatozoa: this reflects sperm
production by the testes and the patency of the post-
testicular duct system
• Sperm concentration: related to fertilization and
pregnancy rates, is influenced by the volume of the
secretions from the seminal vesicles and prostate and is not
a specific measure of testicular function.
Sperm Concentration (million/ ml) & Total count (million/ ejaculate)
63. Sperm Concentration (million/ ml) & Total count (million/ ejaculate)
Total (n = 211)
Mentions concentration (conc) 206
Proportions mentioning Conc 96.630%
Mentions total count (TC) 34
Proportions mentioning TC 16.114%
Mentions both conc and TC 32
Proportions mentioning both conc and TC 15.166%
Mentions neither conc nor TC 3
Proportions mentioning neither conc nor TC 1.422%
64. Sperm Concentration (million/ ml) & Total count (million/ ejaculate)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions concentration (conc) 15 191 206
Proportions mentioning Conc 100% 97.449% 96.630%
P value 0.5287 (Not Significant)
Mentions total count (TC) 34
Proportions mentioning TC 83.886%
Mentions both conc and TC 32
Proportions mentioning both conc and TC 15.166%
Mentions neither conc nor TC 3
Proportions mentioning neither conc nor TC 1.422%
65. Sperm Concentration (million/ ml) & Total count (million/ ejaculate)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions concentration (conc) 15 191 206
Proportions mentioning Conc 100% 97.449% 96.630%
P value 0.5287 (Not Significant)
Mentions total count (TC) 11 23 34
Proportions mentioning TC 73.333% 11.735% 83.886%
P value 0 (Significant)
Mentions both conc and TC 21 32
Proportions mentioning both conc and TC 10.714% 15.166%
Mentions neither conc nor TC 3
Proportions mentioning neither conc nor TC 1.422%
66. Sperm Concentration (million/ ml) & Total count (million/ ejaculate)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions concentration (conc) 15 191 206
Proportions mentioning Conc 100% 97.449% 96.630%
P value 0.5287 (Not Significant)
Mentions total count (TC) 11 23 34
Proportions mentioning TC 73.333% 11.735% 83.886%
P value 0 (Significant)
Mentions both conc and TC 11 21 32
Proportions mentioning both conc and TC 73.333% 10.714% 15.166%
P value 0 (Significant)
Mentions neither conc nor TC 3
Proportions mentioning neither conc nor TC 1.422%
67. Sperm Concentration (million/ ml) & Total count (million/ ejaculate)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions concentration (conc) 15 191 206
Proportions mentioning Conc 100% 97.449% 96.630%
P value 0.5287 (Not Significant)
Mentions total count (TC) 11 23 34
Proportions mentioning TC 73.333% 11.735% 83.886%
P value 0 (Significant)
Mentions both conc and TC 11 21 32
Proportions mentioning both conc and TC 73.333% 10.714% 15.166%
P value 0 (Significant)
Mentions neither conc nor TC 0 3 3
Proportions mentioning neither conc nor TC 0.000% 1.531% 1.422%
P value 0.63122 (Not Significant)
68. Reference value of Sperm Concentration (Million/ ml)
WHO 2010 WHO
1999/ 1992/
1987
(≥20)
WHO
1980
(20-200)
Other
References
No mention
of any
reference
Proportions
using WHO
2010
Mentions
(≥15)
Only
mentions
WHO 2010
Total
(n= 211)
22 4 24 7 20 133 12.322%
69. Reference value of Sperm Concentration (Million/ ml)
WHO 2010 WHO
1999/ 1992/
1987
(≥20)
WHO
1980
(20-200)
Other
References
No mention
of any
reference
Proportions
using WHO
2010
P value
Mentions
(≥15)
Only
mentions
WHO 2010
ART Lab
(n= 15)
4 1 3 7 33.333% 0.01016
(Significant)
Non ART Lab
(n= 196)
18 3 21 7 20 126 10.714%
Total
(n= 211)
22 4 24 7 20 133 12.322%
70. Reference value of Total Sperm Count (Million/ Ejaculate)
WHO 2010 WHO 1999/
1992/ 1987
(≥40)
No
mention of
any
reference
Proportion of those using
WHO 2010
Mentions
(≥39)
Only
mentions
WHO 2010
Total
(n= 211)
14 5 2 190 9.005%
71. Reference value of Total Sperm Count (Million/ Ejaculate)
WHO 2010 WHO 1999/
1992/ 1987
(≥40)
No
mention of
any
reference
Proportion of those using
WHO 2010
P value
Mentions
(≥39)
Only
mentions
WHO 2010
ART Lab
(n= 15)
4 1 10 33.333% 0.00062
(Significant)
Non ART Lab
(n= 196)
10 4 2 180 7.143%
Total
(n= 211)
14 5 2 190 9.005%
72. Sperm Motility (%)
WHO Laboratory Manual for the Examination and Processing of Human Semen FIFTH EDITION. 2010
73. Sperm Motility (%)
Total (n = 211)
Mentions Total Motility (TM) 50
No mention
of TM
Total 161
Calculable 65
Not calculable 96
Describes motility in hours
(0.5, 1, 2, 3, 4)
90
Proportions providing direct/ indirect
estimate of TM
54.502%
74. Sperm Motility (%)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions Total Motility (TM) 6 44 50
No mention
of TM
Total 9 152 161
Calculable 6 59 65
Not calculable 3 93 96
Describes motility in hours
(0.5, 1, 2, 3, 4)
3 87 90
Proportions providing direct/ indirect
estimate of TM
80.000% 52.551% 54.502%
P value 0.0394 (Significant)
75.
76. When to Assess Motility
WHO Laboratory Manual for the Examination and Processing of Human Semen FIFTH EDITION. 2010
77. Sperm Motility in Details (%)
Total
(n = 211)
Mentions Progressive Motility (PM) 109
Classifies PM (Grade A, Grade B) 17
No mention of PM 102
Proportion mentioning PM 51.659%
Mentions Non Progressive Motility (NPM) 103
Mentions Non motile Sperms 103
Only mentions “Non Motile Sperms”
Mentions all 3 categories- PM, NPM and Non-motile Sperms 96
Proportion mentioning all 3 categories 48.979%
78. Sperm Motility in Details (%)
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions Progressive Motility (PM) 12 97 109
Classifies PM (Grade A, Grade B) 17
No mention of PM 102
Proportion mentioning PM 51.659%
P value
Mentions Non Progressive Motility (NPM) 103
Mentions Non motile Sperms 103
Only mentions “Non Motile Sperms”
Mentions all 3 categories- PM, NPM and Non-motile Sperms 96
Proportion mentioning all 3 categories 48.979%
P value
79. Sperm Motility in Details (%)
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions Progressive Motility (PM) 12 97 109
Classifies PM (Grade A, Grade B) 3 14 17
No mention of PM 102
Proportion mentioning PM 51.659%
P value
Mentions Non Progressive Motility (NPM) 103
Mentions Non motile Sperms 103
Only mentions “Non Motile Sperms”
Mentions all 3 categories- PM, NPM and Non-motile Sperms 96
Proportion mentioning all 3 categories 48.979%
P value
80. Sperm Motility in Details (%)
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions Progressive Motility (PM) 12 97 109
Classifies PM (Grade A, Grade B) 3 14 17
No mention of PM 3 99 102
Proportion mentioning PM 80.000% 49.489% 51.659%
P value 0.0226 (Significant)
Mentions Non Progressive Motility (NPM) 103
Mentions Non motile Sperms 103
Only mentions “Non Motile Sperms”
Mentions all 3 categories- PM, NPM and Non-motile Sperms 96
Proportion mentioning all 3 categories 48.979%
P value
81. Sperm Motility in Details (%)
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions Progressive Motility (PM) 12 97 109
Classifies PM (Grade A, Grade B) 3 14 17
No mention of PM 3 99 102
Proportion mentioning PM 80.000% 49.489% 51.659%
P value 0.0226 (Significant)
Mentions Non Progressive Motility (NPM) 11 92 103
Mentions Non motile Sperms 103
Only mentions “Non Motile Sperms”
Mentions all 3 categories- PM, NPM and Non-motile Sperms 96
Proportion mentioning all 3 categories 48.979%
P value
82. Sperm Motility in Details (%)
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions Progressive Motility (PM) 12 97 109
Classifies PM (Grade A, Grade B) 3 14 17
No mention of PM 3 99 102
Proportion mentioning PM 80.000% 49.489% 51.659%
P value 0.0226 (Significant)
Mentions Non Progressive Motility (NPM) 11 92 103
Mentions Non motile Sperms 11 92 103
Only mentions “Non Motile Sperms”
Mentions all 3 categories- PM, NPM and Non-motile Sperms 96
Proportion mentioning all 3 categories 48.979%
P value
83. Sperm Motility in Details (%)
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions Progressive Motility (PM) 12 97 109
Classifies PM (Grade A, Grade B) 3 14 17
No mention of PM 3 99 102
Proportion mentioning PM 80.000% 49.489% 51.659%
P value 0.0226 (Significant)
Mentions Non Progressive Motility (NPM) 11 92 103
Mentions Non motile Sperms 11 92 103
Only mentions “Non Motile Sperms” 3
Mentions all 3 categories- PM, NPM and Non-motile Sperms 96
Proportion mentioning all 3 categories 48.979%
P value
84. Sperm Motility in Details (%)
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions Progressive Motility (PM) 12 97 109
Classifies PM (Grade A, Grade B) 3 14 17
No mention of PM 3 99 102
Proportion mentioning PM 80.000% 49.489% 51.659%
P value 0.0226 (Significant)
Mentions Non Progressive Motility (NPM) 11 92 103
Mentions Non motile Sperms 11 92 103
Only mentions “Non Motile Sperms” 3
Mentions all 3 categories- PM, NPM and Non-motile Sperms 10 86 96
Proportion mentioning all 3 categories 66.667% 43.876% 48.979%
P value 0.08726 (Not Significant)
85. Reference value of Total Motility (%)
WHO 2010 WHO 1999/
1992/ 1987
(≥50)
WHO 1980
(≥60)
No mention
of any
reference
Proportion
of those
using WHO
2010
Mentions
(≥40)
Only mentions
WHO 2010
Total
(n= 211)
20 4 18 4 165 11.374%
86. Reference value of Total Motility (%)
WHO 2010 WHO 1999/
1992/ 1987
(≥50)
WHO 1980
(≥60)
No mention
of any
reference
Proportion
of those
using WHO
2010
P value
Mentions
(≥40)
Only mentions
WHO 2010
ART Lab
(n= 15)
3 1 3 8 26.667% 0.05238
(Not
Significant)
Non ART Lab
(n= 196)
17 3 15 4 157 10.204%
Total
(n= 211)
20 4 18 4 165 11.374%
87. Reference value of Progressive Motility (%)
WHO 2010 WHO 1999/
1992/ 1987
(≥50
Grade A+B or
≥25% Grade A)
WHO 1980
(≥2 Forward
progression,
scale 0-3)
No mention
of any
reference
Proportion
s using
WHO 2010
Mentions
(≥32-
Grade A + B)
Only
mentions
WHO 2010
Total
(n= 211)
18 4 15 2 172 10.427%
88. Reference value of Progressive Motility (%)
WHO 2010 WHO 1999/
1992/ 1987
(≥50
Grade A+B or
≥25% Grade A)
WHO 1980
(≥2 Forward
progression,
scale 0-3)
No mention
of any
reference
Proportion
s using
WHO 2010
P value
Mentions
(≥32-
Grade A + B)
Only
mentions
WHO 2010
ART Lab
(n= 15)
3 1 3 8 26.667% 0.03236
(Significant)Non ART Lab
(n= 196)
15 3 12 2 164 9.184%
Total
(n= 211)
18 4 15 2 172 10.427%
89. Sperm Morphology (%)
WHO Laboratory Manual for the Examination and Processing of Human Semen FIFTH EDITION. 2010
91. Sperm Morphology (%)
Total (n = 211)
Mentions Normal Morphology (%) 162
Not mentioning normal morphology 49
Proportion mentioning normal morphology 48.815%
Mentions Abnormal Morphology (%) in total 131
Mentions details of
abnormal
morphology
Structured and
systematic
65
Unorganized way
Only mentions “Abnormal Morphology”
No mention of abnormal Morphology 70
92. Sperm Morphology (%)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions Normal Morphology (%) 15 147 162
Not mentioning normal morphology 0 49 49
Proportion mentioning normal morphology 100% 76.020% 48.815%
P value 0.03156 (Significant)
Mentions Abnormal Morphology (%) in total 131
Mentions details of
abnormal
morphology
Structured and
systematic
65
Unorganized way
Only mentions “Abnormal Morphology”
No mention of abnormal Morphology 70
93. Sperm Morphology (%)
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
Mentions Normal Morphology (%) 15 147 162
Not mentioning normal morphology 0 49 49
Proportion mentioning normal morphology 100% 76.020% 48.815%
P value 0.03156 (Significant)
Mentions Abnormal Morphology (%) in total 14 127 131
Mentions details of
abnormal
morphology
Structured and
systematic
11 38 65
Unorganized way 16
Only mentions “Abnormal Morphology” 20 20
No mention of abnormal Morphology 1 69 70
94. Reference value of Morphology (%)
WHO 2010 WHO
1999
(≥14)
WHO
1992
(≥30)
WHO
1987
(≥50)
WHO
1980
(≥80.5)
No
mention of
any
reference
Proportion of
those using
WHO 2010
Mentions
(≥4)
Only
mentions
WHO 2010
Total
(n= 211)
19 4 11 5 1 2 169 10.900%
95. Reference value of Morphology (%)
WHO 2010 WHO
1999
(≥14)
WHO
1992
(≥30)
WHO
1987
(≥50)
WHO
1980
(≥80.5)
No
mention of
any
reference
Proportion of
those using
WHO 2010
P value
Mentions
(≥4)
Only
mentions
WHO 2010
ART Lab
(n= 15)
4 1 3 7 33.333% 0.00386
(Significant)
Non ART
Lab
(n= 196)
15 3 8 5 1 2 162 9.184%
Total
(n= 211)
19 4 11 5 1 2 169 10.900%
96. • Sperm vitality, as estimated by assessing the membrane integrity of
the cells, may be determined routinely on all samples, but is especially
important for samples with less than about 40% progressively motile
spermatozoa.
• This test can provide a check on the motility evaluation, since the
percentage of dead cells should not exceed (within sampling error) the
percentage of immotile spermatozoa. The percentage of viable cells
normally exceeds that of motile cells.
Sperm Vitality (%)
97. Sperm Vitality (%)
Total
(n = 211)
Mentions Vitality 37
Does not mention vitality 174
Proportion mentioning Vitality 17.536%
98. Sperm Vitality (%)
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions Vitality 7 30 37
Does not mention vitality 8 166 174
Proportion mentioning Vitality 46.667% 15.306% 17.536%
P value 0.00208 (Significant)
99. Reference value of Vitality (%)
WHO 2010 WHO
1999/
1992
(≥75)
WHO
1987
(≥50)
No mention of
any reference
Proportion of
those using
WHO 2010
Mentions
(≥58)
Only
mentions
WHO 2010
Total
(n= 211)
14 4 5 188 8.531%
100. Reference value of Vitality (%)
WHO 2010 WHO
1999/
1992
(≥75)
WHO
1987
(≥50)
No mention of
any reference
Proportion of
those using
WHO 2010
P value
Mentions
(≥58)
Only
mentions
WHO 2010
ART Lab
(n= 15)
3 1 11 26.667% 0.00906
(Significant)Non ART Lab
(n= 196)
11 3 5 177 7.143%
Total
(n= 211)
14 4 5 188 8.531%
101. • 1. Epithelial cells from the genitourinary tract
• 2. Leukocytes (Pus Cells) and immature germ cells, collectively referred
to as “round cells” (Johanisson et al., 2000).
• Pus cells can be more precisely identified and quantified by detecting
peroxidase activity or the antigen CD45
• There is currently no reference range for peroxidase-positive cells in
semen from fertile men.
• Pending additional evidence, this manual retains the consensus value of
1.0 × 106 peroxidase-positive cells per ml as a threshold value.
Non-sperm cells (106/mL)
102. Non-sperm cells (106/mL)
Total
(n = 211)
Mentions other cells 201
Only “Pus Cells” 31
Only “Round Cells” 3
“Pus” + “Epithelial” Cells 80
“Round” + “Epithelial” Cells 1
“Pus” + “Round” Cells 10
“Pus” + “Epithelial” + “Round” Cells 76
Does not mention other cells 10
Proportion mentioning other cells 95.261%
103. Non-sperm cells (106/mL)
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions other cells 14 187 201
Only “Pus Cells” 3 28 31
Only “Round Cells” 1 2 3
“Pus” + “Epithelial” Cells 2 78 80
“Round” + “Epithelial” Cells 0 1 1
“Pus” + “Round” Cells 0 10 10
“Pus” + “Epithelial” + “Round” Cells 8 68 76
Does not mention other cells 1 9 10
Proportion mentioning other cells 93.333% 95.408% 95.261%
P value 0.71884 (Not Significant)
104. Reference value of Round/ Pus Cells (106/mL)
WHO 2010/ 1999/ 1992/ 1987 No mention of any
reference
Proportion of
those using
WHO 2010
Mentions
(<1)
Only mentions
WHO 2010
Total
(n= 211)
7 4 200 5.213%
105. Reference value of Round/ Pus Cells (106/mL)
WHO 2010/ 1999/ 1992/ 1987 No mention of any
reference
Proportion of
those using
WHO 2010
P value
Mentions
(<1)
Only mentions
WHO 2010
ART Lab
(n= 15)
4 1 10 33.333% 0
(Significant)Non ART Lab
(n= 196)
3 3 190 3.061%
Total
(n= 211)
7 4 200 5.213%
107. Total
(n = 211)
Abstinence Period (AP) 195
Mentions CT 103
Mentions ET 52
Mentions Site of Collection 104
Mentions Completeness of Collection 102
Mentions Method of Collection 65
Volume 210
Liquefaction Time (LT) 163
Viscosity 156
pH 184
Appearance 195
Agglutination 47
Mentions concentration (conc) of sperms 206
Mentions total count (TC) of sperms 34
Mentions Total Motility (TM) 50
Mentions Progressive Motility (PM) 109
Mentions Normal Morphology (%) 162
Mentions Vitality 37
Mentions Non-Sperm cells 201
108. ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
P value
Abstinence Period (AP) 15 180 195 0.25014
Mentions CT 11 92 103 0.04884 (Significant)
Mentions ET 5 47 52 0.41794
Mentions Site of Collection 12 92 104 0.01352 (Significant)
Mentions Completeness of Collection 12 90 102 0.01078 (Significant)
Mentions Method of Collection 5 60 65 0.82588
Volume 15 195 210 0.77948
Liquefaction Time (LT) 13 150 163 0.36812
Viscosity 11 145 156 0.56192
pH 9 175 184 0.00108 (Significant)
Appearance 14 181 195 0.88866
Agglutination 10 37 47 0 (Significant)
Mentions concentration (conc) of sperms 15 191 206 0.5287
Mentions total count (TC) of sperms 11 23 34 0 (Significant)
Mentions Total Motility (TM) 6 44 50 0.0394 (Significant)
Mentions Progressive Motility (PM) 12 97 109 0.03236 (Significant)
Mentions Normal Morphology (%) 15 147 162 0.03156 (Significant)
Mentions Vitality 7 30 37 0.00208 (Significant)
Mentions Non-Sperm cells 14 187 201 0.71884
109. ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n =
211)
P value
Volume 6 28 34 0.00906 (Significant)
Liquefaction Time (LT) 4 34 38 0.36282
Viscosity 3 28 31 0.50286
pH 6 41 47 0.19706
Agglutination 2 8 10 0.1031
Concentration (conc) of sperms 5 21 26 0.01016 (Significant)
Total count (TC) of sperms 5 14 19 0.00062 (Significant)
Total Motility (TM) 4 20 24 0.05238
Progressive Motility (PM) 4 18 22 0.03236 (Significant)
Normal Morphology (%) 5 18 23 0.00386 (Significant)
Vitality 4 14 18 0.00906 (Significant)
Non-Sperm cells 5 6 11 0 (Significant)
Reference values as per WHO 2010
110. Mentions “WHO Reference”
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions “WHO 2010” 3 13 16
1- All specific Reference Value
1- No specific Reference Value
1- Volume and total count 2010.
Sperm Concentration, TM, PM,
Morphology 1999 (“HYBRID Reference”)
No Ref for Viscosity and Vitality
3- No specific Reference
Value
9- Some Reference Value but
not all
1- Volume 2010,
Sperm concentration, TM,
PM, Morphology 1999
(“HYBRID Reference”)
Mentions “WHO 1999” 1 1
Mentions “WHO” but no
specific year
1 5 6
Does not mention
“WHO”
11 177 188
Proportion mentioning
“WHO 2010”
20.000% 6.633% 7.583%
111. Mentions “WHO Reference”
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions “WHO 2010” 3 13 16
1- All specific Reference Value
1- No specific Reference Value
1- Volume and total count 2010.
Sperm Concentration, TM, PM,
Morphology 1999 (“HYBRID Reference”)
No Ref for Viscosity and Vitality
3- No specific Reference
Value
9- Some Reference Value but
not all
1- Volume 2010,
Sperm concentration, TM,
PM, Morphology 1999
(“HYBRID Reference”)
Mentions “WHO 1999” 1 1
Mentions “WHO” but no
specific year
1 5 6
Does not mention
“WHO”
11 177 188
Proportion mentioning
“WHO 2010”
20.000% 6.633% 7.583%
P value 0.0601 (Not Significant)
112. Overall Impression and Compatibility with WHO 2010 Guideline
Total
(n = 211)
Mentions overall impression 54
No mention of overall impression 157
Impression correct
(As per WHO 2010)
41
Impression partially correct
(As per WHO 2010)
2
Impression totally incorrect
(As per WHO 2010)
11
Proportion providing correct impression 75.926%
113. Overall Impression and Compatibility with WHO 2010 Guideline
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Mentions overall impression 9 45 54
No mention of overall impression 6 151 157
Impression correct
(As per WHO 2010)
6 35 41
Impression partially correct
(As per WHO 2010)
1 1 2
Impression totally incorrect
(As per WHO 2010)
2 9 11
Proportion providing correct impression 66.667% 77.778% 75.926%
P value 0.03662 (Significant)
114. Laboratories TOTALLY complying with WHO 2010 Guidelines
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
All Values as per 2010 1 1 2
“Most” of these values 2 6 8
All References as per 2010 1 1 2
“Most” of the References 0 10 10
All Values and All References 1 1 2
Proportion providing All Values and
references
6.667% 0.510% 0.948%
115. Laboratories TOTALLY complying with WHO 2010 Guidelines
ART Lab (n= 15) Non-ART Lab (n= 196) Total (n = 211)
All Values as per 2010 1 1 2
“Most” of these values 2 6 8
All References as per 2010 1 1 2
“Most” of the References 0 10 10
All Values and All References 1 1 2
Proportion providing All Values and
references
6.667% 0.510% 0.948%
P value 0.01778 (Significant)
116. Laboratories complying with WHO 2010 Guidelines w.r.t.
“Important” Parameters
(pH. Volume. Concentration, Count, Morphology, Motility)
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total (n = 211)
All Values as per 2010 3 5 8
All References as per 2010 1 5 6
All Values and All References 1 5 6
Proportion providing All Values and
references
6.667% 2.551% 2.844%
P value 0.35758 (Not Significant)
118. Keel BA, Stembridge TW, Pineda G, Serafy NT Sr. Lack of standardization in
performance of the semen analysis among laboratories in the United States. Fertil
Steril 2002;78:603–8.
• 77% and 59% reported sperm count and motility, respectively, according
to the WHO guidelines
• 35% of laboratories were either not familiar with the WHO manual or did
not have a copy of it in their laboratory
Baker DJ, Paterson MA, Klassen J, Wyrick-Glatzel J. Semen evaluations in the
clinical laboratory. How well are they performed? Lab Med 1994;25:509–14.
• sperm count, motility, and morphology were reported in 47%, 81%, and
78%, respectively.
119. Penn HA, et al. National semen analysis reference range reporting: adherence to the 1999 World Health
Organization guidelines 10 years later. Fertil Steril 2011;95:2320–3.
ART
Lab
(n= 15)
Non-
ART
Lab
(n=
196)
P value
Volume 6 28 0.00906 (Significant)
pH 6 41 0.19706
Concentration 5 21 0.01016 (Significant)
Total count 5 14 0.00062 (Significant)
Total Motility 4 20 0.05238
Progressive
Motility
4 18 0.03236 (Significant)
Normal
Morphology
5 18 0.00386 (Significant)
120. Murray KS, et al. The effect of the new 2010 World Health Organization criteria
for semen analyses on male infertility. Fertil Steril 2012;98:1428–31
• The 2010 reference values result in some infertile men being
reclassified as fertile if status is based on semen analysis alone.
• This may lead to fewer men being referred for proper infertility
evaluation or treatment.
ART Lab
(n= 15)
Non-ART Lab
(n= 196)
Total
(n = 211)
Impression correct
(As per WHO 2010)
6 35 41
Impression partially correct
(As per WHO 2010)
1 1 2
Impression totally incorrect
(As per WHO 2010)
2 9 11
Proportion providing correct impression 66.667% 77.778% 75.926%
121. Limitations
• Methods used to assess seminal parameters
• Small Number
• Regional Variation
• Quality Control (“Acceptable Difference”)
• Reference values do not attest to the quality of the actual semen
analysis or the accuracy of the measurement, both of which are
separate issues of quality assurance and were not the subject of this
study
122. Conclusion
• The adherence to the 2010 WHO semen analysis reference values is low
among all laboratories.
• Non-ART laboratories adhered to the recommendations less than ART
laboratories.
• Reference range parameters have changed over the years and are
controversial but remain the mainstay to define subfertility for men;
provide threshold for referral to specialists; and provide some guidance
to initiate potential investigations and treatment.
• More education and training of clinicians and laboratories is needed to
understand and report reference