The document outlines key steps and considerations for establishing and managing a successful IVF center, focusing on infrastructure, personnel training, and equipment needed. It highlights the importance of quality control (QC) and quality assurance (QA) to maintain optimal laboratory performance and ensure successful outcomes. Success is evaluated through financial performance and clinical metrics such as pregnancy and growth rates.

1. How to Establish a
successful IVF Center

2. How to Define success!
Maintain
performance
Grow
flow
Expand

3. IVF Center
IVF
Laboratory
Viable
embryos
Clinical team
Ob/Gyn
-Ovulation induction
- Monitoring
- Ovum pick-upClinical team
Ob/Gyn

4. How to Establish!
• KnowHow
Available or not
• Budget
(small vs large)
• Team
(one man show vs
group)
• District : central vs
periphary
• Target : Upper class
vs middle class
• Aim : finance /
prestigue / adjuvant
service

5. Site selection
Inside a hospital: UNIT
- To benefit from the infrastructure of :
• Electric generator
• Laundry facilities
• Sterilization facilities

6. Specialised Center
• Independent
• Focused
• Fame : rapid and easy
• Much more risk taking
• High running costs

7. Design
- Enough space to allow equipment
installation and free movement of
personnel
- Enough space to allow for expansion
- allow enough time after construction
before installing equipments and use.

8. So How to make ur decision?
• Usually circumstances drive ur decision
• But none of the previous factors will make
it succeeds : they will help u for the setup
• For success: it is all about Personnel

9. Establishing An
IVF Center
1- Training of personnel.
2- Equipment selection.

10. Training of personnel
I. Training the IVF laboratory practitioners
• Minimum of one year (hands on) work
II. Training of the IVF clinical team
• Gynecologists working in infertility
• Three months (hands on) work

11. Strict System
• From the start
• Applied to all (no exception)
• Be ready for turn over
• Do not forget training of nurses and
workers (infertility is a special entity)

12. Essential Equipments
I- Microscopes
1- ordinary light microscopes
2- sterio microscopes (inside a laminar flow)
II- CO2 incubators (number & type)

13. Other equipments in the IVF lab
III- centrifuges
IV- refrigerators
V- media preparation
(H2O purification – ph meter – osmometer -
balance)

14. IVF Laboratory should be backed by:
1. Cryopreservation facilities
2. Micromanipulation equipments

15. Clean Room
•HEPA filters
•Positive pressure
•Stainless steel furniture,
smooth, non-porous
walls
•Constant temperature
•Constant UPS

16. Again this is a setup
• What about success? • How to maintain it?

17. Quality Control
& Quality Assurance

18. What is Quality Control (QC)?
QC involves all measures undertaken to
control the quality of:
products equipment
protocols environment
to insure that the IVF Laboratory is
functioning correctly

19. What is Quality Assurance (QA)?
QA is a comprehensive program
QC
Measures of :
- Equipment
- Protocols
- Environment
- Products
Results
reporting
Record
keeping
Treatment
auditing
and
incident
reporting
Education
of
laboratory
staff

20. Benefits of Employing
QC & QA
- Maintain the optimal laboratory performance
- Detect problems before they become
significant.
- Evaluating personnel performance and
motivating staff.

21. Micro droplet – Oil Overlay
VOC’s Filtration Oil Issues
Plastic
Ware
MediapH
Temperature

22. QC Program
routine monitoring
1) Equipment
2) Culture media and consumables
3) The environment
4) Protocols
initial validation +

23. Equipment validation
- Installed by the manufacturer
- Switched on and monitored for a
sufficient time to identify
problems before use in clinical
treatment

24. Quality Control Measures
Range ±
accuracy
MethodFrequencyTestEquipment
± 0.5%
-10 to + 50
± 0.5ºC
0.03 EU/mL
-10 to +50
±1 ºC
- 10 to + 50
± 1 ºC
Fyrite
Thermometer
Sperm
survival
assay
Limulus
amoebocyte
test
Thermometer
Thermometer
3 / week
Daily
as required
Weekly
Daily
Monthly
CO2%
Temperature
Environment
Endotoxin
Temperature
Temperature
Incubator
Water System
Refrigerator
Heated stages

25. Company-manufactured media:
- QC testing of all new batches of culture
media is important because of transport,
and incorrect storage conditions.

26. Air pollutants
Volatile organic compounds (VOCs) and
chemical airborne contaminants (CACs)
can significantly affect culture
conditions

27. Prevention of VOCs
- Consideration should be given to the site
and location of the laboratories
- The use of air purification units
- Positive pressure airflow
- Sealants, toxic glues, paint, should be
avoided

28. Cleaning
- Routine cleaning after every procedure
during work.
- Daily cleaning after work (microscopes
– all surfaces – laminar flows)
- Weekly cleaning
Incubators - laminar flows

29. Assessment of Follicular
Stimulation
 Length of stimulation
A. E2 level
B. No. of mature oocytes
C. Dosage (Type?) of gonadotrophin
 Oocyte response during ICSI
A. post-retrieval
1. Immediate
2. Fertilisation rate

30. What is Quality Assurance (QA)?
QA is a comprehensive program
QC
Measures of :
- Equipment
- Protocols
- Environment
- Products
Results
reporting
Record
keeping
Treatment
auditing
and
incident
reporting
Education
of
laboratory
staff

31. Keeping Records and
Documentation
Accurate documentation and
record keeping of all aspects of
the scheme is fundamental to
the success of an QA program

32. Paper Work Design
- Detailed information
- Easy information retrieval
- Security of the documents

33. Monitoring laboratory
performance
- Auditing fertilization and embryo
cleavage rates and embryo
quality
- Auditing pregnancy rate,
implantation rate, and birth rate.

34. Appraisal of
Performance
Staff evaluation
Equipments evaluation

35. How to Estimate Success?
• Money gain
• Pregnancy rate
• Growth rate

36. If it is money?
• What is the acceptable percent of
profit 20% 40% 50% 100%
• How to reduce running costs !!
• Yearly vs monthly order !!

37. How to Maximize Profit?
• Cafeteria : ? Location
• Auxulliary services: Lab
?? Pharmacy

38. Good Egg

39. Bad Egg

40. Fertilization
•2 Pronuclei (2PN)
•1 day after egg
retrieval

41. Day 3 Embryo

42. Day 3 Embryo

43. Day 3 Embryo

44. Day 3 Embryo

45. Hatching Blastocyst

46. Embryo Transfer

47. Embryo Transfer