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

QUALITY CONTROL IN THE IVF LAB. HOW TO DO IT Gloria Calderón PhD. Factors affecting the success of ART. Diagnosis and therapeutic guidance. Ovarian stimulation Oocyte retrieval IVF procedures. Embryo transfer. Luteal phase treatment. Why?.

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

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  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 2000 cycles/year 6 embryologists 10 technicians 1035 cycles/year 13 (10) embryologists 800 cycles/year 5 embryologists 6 technicians

  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

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

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

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

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

  12. 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.

  13. >18 hours delay in 2PN examination …… affects the number of fertilized oocytes Nagy y col Hum Reprod 9: 1743-8, 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

  14. 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

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

  16. Cohen et al

  17. Laboratory: Key points • Human resources • Laboratory facilities • Quality control

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

  19. Daily record of temperatures, CO2 and pH Eeejelemeheheheheh Jjflflflflflfl lhihhk Refrigerators Warmed plates Incubators

  20. 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: 858-60, 1987 Bavister y Andrews J In Vitro Fertil Embryo Transf 5: 67-75, 1989 Claassen y col Hum Reprod 15: 1586-91, 2000

  21. 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 www.european-accreditation.org IVF LABORATORY´S TECHNICAL COMPETENCE

  22. Accreditation of the IVF laboratory Audits 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: 2241-46, 2000

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

  24. Determination of main pollutants compounds • NO2 • SO2 • Petroleum hydrocarbons (C3-C9) • Toluene • Benzene • Styrene and xylenes

  25. Air quality influence 1994: Laboratory adjacent renovation and construction 1995: New system of air circulation * * • • Boone WR et al. Fertil Steril 1999; 71:150-154

  26. * 52 % 30 % 37.1 % 40.5 % 55 % 48.4 % * 14 % % Pregnancy % Miscarriage % Implantation 1.4 % 10.1% 9.4 % 34.3 % 27.7% Torelló y col MEFS 2001 CODA No CODA % Pregnancy JF Mayer y col 1999, Norfolk USA % Pregnancy % Miscarriage Racowsky y col 1999, Sydney Australia

  27. IVI-BARCELONA RESULTS (OCT2004-JAN2008)

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