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How science is advancing
 

How science is advancing

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    How science is advancing How science is advancing Presentation Transcript

    • How Science is advancing!!
    • N-acetylaysteine (NAC)
      • Mucolytic
      • Recently reported to have insulin senitizing properties
      • Accordingly we used it with C.C to avoid the anti-oestrogenic effect on cervical mucous
    • Observation
      • Improved ovarian response with development of more than one follicle
    • Idea
      • NAC can be a novel combination to CC
    • Clinical Trial
      • The best candidates to this idea are CC resistant cases
    • Keeping in mind
      • NAC has been used safely since long time (Borgstrom et al 1986).
    • Objective
      • to evaluate the effect of NAC adjuvant therapy in women with PCOS resistant to CC.
    • Design
      • prospective RCT,
      • placebo-controlled,
      • double blind
      • Allocation was done using opaque sealed envelopes
    • Patients and Methods
      • Patients:
      • 150 cases diagnosed as CC-resistant PCOS were recruited.
      • Inclusion criteria
      • 1-Normal semen parameters 2-Clomiphene citrate resistant PCOS 3-Normal HSG . 4- No treatment was taken during last 3 ms prior to recruitment.
    • Intervention
      • Participants assigned randomly to receive either
      • NAC 600 mg / twice daily ( group I ) with CC 50 mg / twice daily or placebo ( group II ) with CC 50 mg / twice daily for 5 days starting at day 3 of the cycle .
      • Allocation was done using opaque sealed envelopes
    • Monitoring of the cycle
      • Transvaginal determination of the mean follicular diameter.
      • Measurement of serum E2 levels at time of HCG adminstration.
      • 3. Monitoring intervals were determined by patient response.
    • Then
      • Human chorionic gonadotropin was administered when at least one follicle measured 18 mm
      • Timed intercourse was advised 24-36 hours after hCG injection
    • Success was monitored by
      • A serum progesterone level was checked 6-8 days after the administration of hCG.
      • A serum hCG level was determined 14 days after hCG injection if menses had not yet occurred.
      • Pregnancy was defined as a rise in the serum hCG level on serial determinations at least 2 days apart.
    • Outcomes
      • Primary:
      • Ovulation rate
      • Secondary:
      • pregnancy rate
      • Tolerability
    • Results
      • 150 women with PCO resistant to CC were randomized to
      • CC +NAC: n = 75 (GroupI)
      • CC + placebo: n = 75 (GroupII)
    • Demographics NS 28.5 ± 5.7 30.5 ± 2.6 BMI NS 99.2 ± 12.3 101.3 ± 12.4 B WT (Kg) NS 4.4 ± 2.6 5.0 ± 2.9 Duration (Ys) NS 28.4 ± 5.7 28.9 ± 4.7 Age (Ys) P value Group II Group I Variable
    • Hormonal profile NS 85.9 ± 14.1 81.9 ± 12 Fasting Glucose (mg/dL) NS 17.2 ± 4.4 18.8 ± 4.7 Fasting insulin (U/mL) NS 2.1 2.2 LH/FSH ratio P value Group II Group I Variable
    • Clinical outcomes of both groups
    • Pregnancy rates in patients who received NAC according to their insulin
    • How To Explain
      • Antiapoptotic Odetti et al., 03 .
      • Antioxidant De Mattia et al., 98.
      • Insulin sensitizing effect Fulghesu et al 02.
    • Potential biological activities of NAC
      • Reduces testosterone levels and free androgen index values. Fulghesu et al 02.
      • A safe mucolytic drug.
    • Side effects
      • NAC is generally safe & well tolerated
      • The most common side effects were : 1-Nausea & vomiting. 2-Diarrhea.
      • It is contraindicated in active peptic ulcer disease.
    • Conclusions
      • NAC is a a novel adjuvant treatment for PCOS patients.
      • It is a simple, well tolerated and inexpensive agent.
      • Accepted for publication in Fertil & Steril 2005 Feb
    • STEP II
      • A feasible approach to friendly IVF
    • PILOT STUDY
      • The objective of this study was to examine the use of NAC with clomiphene citrate for ovarian stimulation in assisted conception as a model for “Friendly IVF”
    • Intervention
      • Patients were offered NAC, 1,200 mg/day from day 3-7 of the menstrual cycle with CC (100 mg /day) starting on day 3-7. HCG (10,000 IU) was given when leading follicle(s) were  18mm followed by ICSI
    • RESULTS
      • Twenty women were enrolled in this pilot study with a mean age of 27.3 ± 1.9 and mean BMI of 28.1 ± 0.8.
      • The mean number of follicles >18 mm on the day of HCG injection was 4.8 ± 1.6. The mean number of oocytes retrieved was 3.6±1.2 .
      • Four women got pregnant (20%) [all were single ton pregnancy). The implantation rate was 14.3%. No miscarriages were reported till now.
    • cost of medications
      • the number of NAC sachets used was 6 per day for 5 days making a total of 30 costing 27 E.P plus an average of two fillings of clomid = 18 EP,
      • thus the total cost of medications in NAC-CC / ICSI cycle = 45 E.P (7$) which is considerably less than the average cost of medications in the long protocol of ICSI cycle (about 2000EP) (~450$).
    • CONCLUSION II
      • a simple NAC-CC protocol is compatible with the concept of `friendly IVF', yielding a reasonable pregnancy rate per cycle started. The results of this study should be substantiated in a larger cohort of patients .
      • Thank you