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Pgina 1 QUALITY CONTROL IN THE IVF LAB. HOW TO DO IT Gloria Caldern PhD Slide 2 Pgina 2 Diagnosis and therapeutic guidance. Ovarian stimulation Oocyte retrieval IVF procedures. Embryo transfer. Luteal phase treatment. Factors affecting the success of ART Slide 3 Pgina 3 Laboratory improvements affects directly in the ART programmes results. Programme results are mostly affected by laboratory variations. Why? Rackowsky et al. 11th World Congress on IVF and Human Reproductive Genetics. Sydney, Australia 1999. Slide 4 Pgina 4 Human resources Laboratory facilities Quality control Laboratory: Key points Slide 5 Pgina 5 Human resources 2000 cycles/year 1035 cycles/year 800 cycles/year 5 embryologists 6 technicians 6 embryologists 10 technicians 13 (10) embryologists Slide 6 Pgina 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 Slide 7 Pgina 7 Human resources Laboratory facilities Quality control Laboratory: Key points Slide 8 Pgina 8 Slide 9 Pgina 9 Slide 10 Pgina 10 Slide 11 Pgina 11 Own oocytes/Laboratory % Pregnancy % Implantation EQUIPO IVI 2001 Slide 12 Pgina 12 ICSI / Embryologist EQUIPO IVI 2001 % 2PN % Pregnancy % Implantation Slide 13 Pgina 13 ICSI / Microscope % Pregnancy % Implantation EQUIPO IVI 2001 Slide 14 Pgina 14 ICSI / Incubator % Pregnancy % Implantation EQUIPO IVI 2001 Slide 15 Pgina 15 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. Technical facilities: equipments Slide 16 Pgina 16 > 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 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 >18 hours delay in 2PN examination Slide 17 Pgina 17 Annual maintenance contracts of equipments and filters Daily control of T, CO 2 and pH Daily check of clinical results: early detection of lab problems IVF Laboratory: equipments Slide 18 Pgina 18 Stable culture conditions Mineral oil Warmed surfaces Open incubators as less as possible ---------- Technical facilities: characteristics Slide 19 Pgina 19 Cohen et al Slide 20 Pgina 20 Human resources Laboratory facilities Quality control Laboratory: Key points Slide 21 Pgina 21 Quality control Daily control of temperatures, CO2 pH Embryotoxicity tests Accreditation of the IVF laboratory Slide 22 Pgina 22 Daily record of temperatures, CO2 and pH Eeejelemeheheheheh Jjflflflflflfl lhihhk Refrigerators Warmed plates Incubators Slide 23 Pgina 23 Application of embryotoxicity tests Contact materials Culture medium -1 or 2 cells mouse embryos - Sperm motility Bavister y Andrews J In Vitro Fertil Embryo Transf 5: 67-75, 1989 Claassen y col Hum Reprod 15: 1586-91, 2000 Fleetham y col Fertil Steril 59: 192-6, 1993 Fleeming y col Fertil Steril 47: 858-60, 1987 Slide 24 Pgina 24 Accreditation of the IVF laboratory Legislation and recommendations to ensure quality performance of ART laboratory procedures (USA, UK, Sweden) ESHRE, ASRM, ALPHA EUROPEAN COOPERATION FOR ACCREDITATION www.european-accreditation.org IVF LABORATORYS TECHNICAL COMPETENCE EUROPE Slide 25 Pgina 25 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 Slide 26 Pgina 26 Drugs manufacture Manufacture of accurate optical instrument What about us? Environmental factors Slide 27 Pgina 27 Determination of main pollutants compounds NO 2 SO 2 Petroleum hydrocarbons (C3-C9) Toluene Benzene Styrene and xylenes Slide 28 Pgina 28 Slide 29 Pgina 29 Air quality influence 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 74.160.262.470.769.2 0.032 % > 4 cell embryos 66 # 61 # 78 # 77 # 83 #