A pilot study to assess oral contraceptive (OC) pretreatment in women undergoing controlled ovarian hyperstimulation (COH) in ganirelix acetate cycles

Abstract

Objective: To assess the feasibility and impact of pretreatment with OCs for scheduling women undergoing COH in GnRH antagonist cycles. Design: This was a multicenter, open-label pilot trial of healthy female partners of infertile couples. Materials/Methods: Subjects were females of infertile couples for whom COH and in vitro fertilization (IVF) with or without intracytoplasmic sperm injection (ICSI) were indicated. The subjects were ≥18 and ≤35 years of age with normal menstrual cycles. Their body mass index had to be less than 29 kg/m2 with a weight limit of >50 kg and <90 kg. Subjects took OCs (Desogen®) once daily for 14 to 21 days beginning on day 1 to 3 of the menstrual cycle. Recombinant follicle stimulating hormone (rFSH, Follistim) at a starting dose of 225 IU was administered subcutaneously once daily beginning on the fourth day after discontinuation of the OC. Ganirelix acetate (250 g/day) was started on day 6 of rFSH treatment or when the lead follicle reached a mean diameter of 12 mm. Human chorionic gonadotropin (hCG) was administered on the first day that 3 follicles with a diameter of greater than 17 mm were observed by ultrasonography. Results: The study is ongoing and to date 77 patients have been enrolled, 69 have been treated with the OC, 61 have received hCG, 59 have undergone oocyte retrieval, and 58 have had embryo transfer. An average of 2.2 embryos was transferred per patient. Of the subjects who have had oocyte retrieval, the mean number of oocytes retrieved (± standard deviation [SD]) was 16.5 ± 8.5. The mean total rFSH dose was 2458 IU and the mean duration of stimulation was 9 days. The mean number of good-quality embryos (Grades I and II) achieved was 8.5 ± 4.9. Of those patients completed to date who received embryo transfer, the implantation rate was 26% and the pregnancy rate (positive fetal heartbeat at 5 to 6 weeks) was 37%. Conclusions: The preliminary results of this study indicate that OCs can be successfully used to schedule patients prior to COH in ganirelix cycles. Supported by: Supported by Organon Inc, West Orange, New Jersey.