A bioassay procedure is described for quality control testing of various disposable items used in routine IVF procedures. This bioassay is performed over 4 days and uses the survival of human sperm in vitro at room temperature to assess which products are suitable for use. New products were tested for cytotoxicity using a general screening method and subsequent batches of every suitable item tested to detect interbatch variation. Products were considered suitable or unsuitable for use depending upon a calculated sperm survival index. Two main types of product were found to be cytotoxic, namely certain brands of syringe and surgical gloves, the common feature of both being the presence of rubber components. The bioassay was also used to investigate further the cytotoxic effect of the powdered and starch-free surgical gloves. The cytotoxic substances from both types of surgical glove were readily transferred to an embryo replacement catheter by touch, and washing of the gloves reduced this effect only moderately. The bioassay has proved inexpensive and convenient but more importantly it has been invaluable for detecting potential sources of cytotoxicity before they are introduced into a standard IVF protocol.

Objectives To analyse the incidence and factors associated with the ovarian hyper‐stimulation syndrome (OHS) in our IVF/GIFT programme before and after the introduction of a strategy to cryopreserve all embryos from women judged to be at risk. Design Two hundred forty‐one consecutive IVF/GIFT cycles from January to December 1989. Setting Specialist fertility unit, Manchester, UK. Interventions Pituitary suppression was effected by a daily subcutaneous injection of buserelin (500 μg) beginning 7 days before the expected menses. The ovarian stimulation was with variable amounts of human menopausal gonadotrophin. Ovulation was induced with 10 000 i.u. human chorionic gonadotrophin (hCG). From January to May (period A), gametes/embryos were replaced and 2000 i.u. hCG given, irrespective of the serum oestradiol (E2) concentration. From June to December (period B), all the embryos from women with an E2>3500 pg/ml on the day of ovulatory trigger were electively cryopreserved. Main outcome measures Serum E2, features of moderate or severe OHS, clinical pregnancies. Results The OHS occurred in 10/105 (9.5%) and 12/136 (8.8%) cycles in periods A and B, respectively. Fewer women (6% versus 60%, P<0.05) who had their embryos cryopreserved developed severe OHS compared with women with an E2 >3500 pg/ml who became pregnant after gamete/embryo transfer in period A. The main factors associated with the development of OHS were serum E2 concentrations >3500 pg/ml, whether gamete/embryos were replaced and the additional hCG given, the occurrence of a pregnancy and the presence of polycystic ovary disease. Conclusion The elective cryopreservation of all embryos from women with high E2 levels reduced the severity, but not the incidence of symptomatic OHS.

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Objective To compare the outcome of in vitro fertilisation (IVF) and gamete intrafallopian transfer (GIFT) cycles in women with or without ultrasound features of polycystic ovary syndrome (PCOS). Design A consecutive series from January to December 1989. Subjects Twenty‐five women with PCOS scheduled for assisted conception. The controls were 139 women with normal ovaries. Setting A single centre specialist fertility unit, Manchester, UK. Interventions Pituitary desensitisation was with buserelin. In the PCOS group ovarian stimulation was with 1 ampoule (75 iu FSH) of hMG/day in 12 women (Group I) and two ampoules/day in 13 (Group II). The controls (Group III) were given two ampoules of hMG daily. Human chorionic gonadotrophin (hCG; 10 000 iu) was given when three follicles measured 20 mm diameter. Main outcome measures Serum oestradiol (E2) concentrations, number of follicles, clinical pregnancies, features of the ovarian hyperstimulation syndrome (OHS). Results Women with PCOS (Groups I or II) had more follicles 14 mm diameter on the day of the hCG injection (P<0.005), higher serum E2 concentrations on the day after the hCG (P<0.05) and more oocytes retrieved (P<0.05) than the controls. The OHS was more prevalent in those with PCOS (32% versus 6.5%; P<0.05). The clinical pregnancy rate per embryo transfer (27% versus 22%) or gamete transfer (25% versus 39%) and the rate of spontaneous miscarriage (33% versus 12%) were not statistically different. Conclusions The pregnancy rate and outcome of pregnancy following IVF or GIFT in women with or without PCOS are similar. Women with PCOS are at a higher risk of developing OHS.

From 1st June 1989 to 31st May 1991, 78 women with a serum oestradiol level greater than 3500 pg/ml on the day of the ovulatory trigger, following pituitary suppression with buserelin and ovarian stimulation with human menopausal gonadotrophins (HMG), had all their embryos electively cryopreserved at the pronucleate stage to minimize the risk of developing ovarian hyperstimulation syndrome (OHS). Treatment with buserelin was continued in the luteal phase. A median of 19 oocytes (range 7-43) was obtained and 12 embryos (range 1-37) frozen per cycle. Twenty-one (27%) women developed OHS (six severe). Women developing OHS had higher (P less than 0.05) serum oestradiol concentrations on the 7th day after oocyte retrieval, compared to those who did not. No differences were found for any of the following criteria: aetiology of infertility, age, total dose of HMG, number of oocytes, fertilization rate or freeze-thaw survival of embryos. Subsequently, 125 frozen-thawed embryo replacements have been undertaken, using buserelin and hormone replacement therapy (HRT) (n = 93) or natural cycles (n = 32). The overall freeze-thaw survival and implantation rates per embryo were 71.8 and 11.7%, respectively. The pregnancy rates in natural cycles (19%) and buserelin/HRT cycles (29%) were not significantly different.