Prevention of severe ovarian hyperstimulation syndrome (OHSS) in IVF patients by steroidal ovarian suppression--a prospective randomized study.

Ovarian hyperstimulation syndrome (OHSS) is the major complication associated with artificial reproductive technologies. The aim of this study was to assess the potential of exogenous steroids to prevent OHSS without adversely affecting pregnancy rate. A prospective and randomized study including 945 consecutive cycles in 603 women (mean age 28.6 years) was carried out to evaluate the efficiency of high-dose progesterone and oestradiol administration during the luteal phase to prevent OHSS. After ovulation induction, patients were allocated by a series of computer-generated random numbers to receive either 5000 iu human chorionic gonadotrophin (hCG) 4 and 8 days after embryo transfer (group 1, n = 534) or 500 mg hydroxy-progesterone caproate and 10 mg oestradiol valerate on days 2, 6, 10 and 14 after embryo transfer (group 2, n = 411), by i.m. injection. Total pregnancy rate was 24% (97 of 411) and 23% (121 of 534), and median serum progesterone concentrations on day 15 after embryo transfer were 5.8 ng ml(-1) (range 0.1-298) and 0.1 ng ml(-1) (range 0.1-372) in groups 1 and 2, respectively (P = 0.001). One hundred and sixty-three (30.5%) women in group 1 and 22 (5.4%) women in group 2 developed signs of OHSS (P < 0.0001). These results indicate that steroidal ovarian suppression during the luteal phase is a promising tool to reduce the incidence and severity of OHSS in a high-risk population without compromising the pregnancy rate.