Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation

Objective: To assess the efficacy, safety, and local tolerance of ganirelix acetate for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH). Design: Phase III, multicenter, open-label randomized trial. Setting: In vitro fertilization (IVF) centers in North America. Patient(s): Healthy female partners (n = 313) in subfertile couples for who m COH and IVF or intracytoplasmic sperm injection were indicated. Intervention(s): Patients were randomized to receive one COH cycle with gan irelix or the reference treatment, a long protocol of leuprolide acetate in conjunction with follitropin-beta for injection. Outcome Measure(s): Number of oocytes retrieved, pregnancy rates, endocrine variables, and safety variables. Result(s): The mean number of oocytes retrieved per attempt was 11.6 in the ganirelix group and 14.1 in the leuprolide group. Fertilization rates were 62.4% and 61.9% in the ganirelix and leuprolide groups, respectively, and implantation rates were 21.1% and 26.1%. Clinical and ongoing pregnancy rat es per attempt were 35.4% and 30.8% in the ganirelix group and 38.4% and 36 .4% in the leuprolide acetate group. Fewer moderate and severe injection si te reactions were reported with ganirelix (11.9% and 0.6%) than with leupro lide (24.4% and 1.1%). Conclusion(s): Ganirelix is effective, safe, and well tolerated. Compared w ith leuprolide acetate, ganirelix therapy has a shorter duration and fewer injections but produces a similar pregnancy rate. (C) 2001 by American Soci ety for Reproductive Medicine.