1. QUALITY CONTROL IN THE IVF LAB.
HOW TO DO IT
Gloria Calderón PhD

2. Factors affecting the success of ART
Diagnosis and therapeutic guidance.
Ovarian stimulation
Oocyte retrieval
IVF procedures.
Embryo transfer.
Luteal phase treatment.

3. Why?
Laboratory improvements affects directly in the ART programmes results.
Programme results are mostly affected by laboratory variations.
Rackowsky et al. 11th World Congress on IVF and Human Reproductive Genetics. Sydney, Australia 1999.

4. Laboratory: Key points
Human resources
Laboratory facilities
Quality control

5. Human resources 6 embryologists 10 technicians 1035 cycles/year

6. ENOUGH TIME FOR EVERY CYCLE
Optimal ratio of laboratory staff to ensure high attention during the procedures
CONCENTRATION
Each sample must be handled individually.
RESPONSABILITY
For the correct application of the protocols in the laboratory during ART procedures

7. Laboratory: Key points
Human resources
Laboratory facilities
Quality control

11. Own oocytes/Laboratory
% Pregnancy
% Implantation
EQUIPO IVI 2001

12. ICSI / Embryologist
% 2PN
% Pregnancy
% Implantation
EQUIPO IVI 2001

13. ICSI / Microscope
% Pregnancy
% Implantation
EQUIPO IVI 2001

14. ICSI / Incubator
% Pregnancy
% Implantation
EQUIPO IVI 2001

15. Technical facilities: equipments
LAMINAR FLOW HOODS: Satisfactory number to avoid 2 procedures at the same time.
MICROSCOPES: Satisfactory number to avoid procedure delays.
INCUBATORS: 1 incubator/2 patients + working incubators.

16. >18 hours delay in 2PN examination ……
affects the number of fertilized oocytes
Nagy y col Hum Reprod 9: , 1994
Suppinyopong y col J med Assoc Thai 83: 500-3, 2001
> 6 hours between denudation and ICSI or oocyte retrieval and ICSI
Oocyte activation significantly increased
Fertilization rates significantly decreased
Albert y col C-59, SEF 2000

17. IVF Laboratory: equipments
Annual maintenance contracts of equipments and filters
Daily control of Tª, CO2 and pH
Daily check of clinical results: early detection of lab problems

18. Technical facilities: characteristics
Stable culture conditions
Mineral oil
Warmed surfaces
Open incubators as less as possible -

19. Cohen et al

20. Laboratory: Key points
Human resources
Laboratory facilities
Quality control

21. Quality control Daily control of temperatures, CO2 pH
Embryotoxicity tests
Accreditation of the IVF laboratory

22. Refrigerators Warmed plates Incubators Daily record of temperatures,
CO2 and pH
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Refrigerators
Warmed plates
Incubators

23. Application of embryotoxicity tests
Contact materials
Culture medium
-1 or 2 cells mouse embryos
-Sperm motility
Fleetham y col Fertil Steril 59: 192-6, 1993
Fleeming y col Fertil Steril 47: , 1987
Bavister y Andrews J In Vitro Fertil Embryo Transf 5: 67-75, 1989
Claassen y col Hum Reprod 15: , 2000

24. EUROPEAN COOPERATION FOR ACCREDITATION
Accreditation of the IVF laboratory
Legislation and recommendations to ensure quality performance of ART laboratory procedures
(USA, UK, Sweden) ESHRE, ASRM, ALPHA
EUROPE
EUROPEAN COOPERATION FOR ACCREDITATION
IVF LABORATORY´S TECHNICAL COMPETENCE

25. Audits Accreditation of the IVF laboratory IVF Laboratory
Administrative questions
Laboratory questions
Clinic questions
IVF Laboratory
- Equipments calibration
- Quality control documentation
- Working manuals of the IVF methods
- Documentation of results
- Dated and signed reports
Gianaroli y col Hum Reprod 15: , 2000

26. Environmental factors
Environmental  factors
Drugs manufacture
Manufacture of accurate optical instrument
What about us?

27. Determination of main pollutants compounds
SO2
Petroleum hydrocarbons (C3-C9)
Toluene
Benzene
Styrene and xylenes

29. Air quality influence
1994: Laboratory adjacent renovation and construction
1995: New system of air circulation
1993
n=71
1994
n=68
1995
n=60
1996
n=47
1997
n=29 p
Pregnancies (%)
25 (35)
11 (16)
12 (20)
15 (32)
17 (59)*
0.003
Fertilization rate
74.1
60.2
62.4
70.7
69.2
0.032
% > 4 cell embryos
66#
61#
78#
77#
83#
<0.001 * * • •
Boone WR et al. Fertil Steril 1999; 71:

38. * * CODA No CODA 52 % 30 % % Pregnancy 40.5 % 37.1 % 1.4 % 14 %
JF Mayer y col 1999, Norfolk USA
40.5 %
37.1 %
1.4 %
14 % *
% Pregnancy
% Miscarriage
Racowsky y col 1999, Sydney Australia
Torelló y col MEFS 2001
% Pregnancy
% Miscarriage
% Implantation
55 %
48.4 %
10.1%
9.4 %
34.3 %
27.7%

44. IVI-BARCELONA RESULTS (OCT2004-JAN2008)
REGULAR
RECIPIENTS
PGD
X AGE
35,07
40,8
38,2
Nb PROC
777
1216
248
Nb TRANSF.
649
1127
140
X EMB. TRANS
1,98
2,0
1,61
PREGNANCY %
54,1
61,3
42,8
IMPLANTATION %
37,5
43,7
35,2
MULTIPLE PREG. %
35,6
40,1
30,0