Flexible use of the GnRH antagonist, ganirelix, according to ultrasound follicular development, in women undergoing controlled ovarian hyperstimulation with recombinant FSH. a multi-center clinical survey

Abstract

Objective: To evaluate efficacy and safety of the flexible use of ganirelix, according to ultrasound follicular development, for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH). Design: Multi-center, open-label, prospective, descriptive. Materials and Methods: Patients for whom COH and IVF or ICSI was indicated were included. Controlled ovarian hyperstimulation with rec.-FSH (Puregon®) started at day 1 to 5 of menses and ganirelix (Orgalutran®) 0.25 mg was injected subcutaneously once daily, starting according to a flexible regimen in function of follicular development: 1.The following day, when one 14 mm follicle was observed by ultrasound.2.The same day, when several 14 mm follicles were observed by ultrasound.3.The same day, when one 15 mm follicle was observed by ultrasound. Ganirelix (Orgalutran®) was continued up to the day that 3 follicles of ≥ 17 mm were observed by ultrasound. Final maturation of the oocytes was induced by administration of 10 000 IU-hCG (Pregnyl®). Luteal phase support was administered according to the reproductive medical center’s usual practice. The primary efficacy parameter was prevention of premature luteinizing hormone (LH) surges. The secondary parameters were the number of oocytes retrieved, pregnancy rates, endocrine parameters, and safety parameters. Results: In total 132 patients with a mean age of 33,61 (± 3.73) years, mean body weight 58,57 kg (±7,35), a mean BMI of 21,81 kg/m2 and a duration of infertility of 41.03 months (2–192) were treated. The causes of infertility were: tubal factor 9.8%, endometriosis: 7.6%, male factor: 44% known infertility: 9.8%, others 29%. Eight patients did not undergo embryo transfer (1 insufficient ovarian response, 1 bad quality embryos that failed fertilization, 1 low and 4 moderate ovarian hyperstimulation syndrome and 1 presence of an endometrial polyp). None of the patients presented a LH surge during the administration of ganirelix (Orgalutran®). The mean number of oocytes retrieved per attempt was 10,84 (SD 7.34), the mean number of embryos transferred was 3.18 (SD 1,12). The fertilization rate was 80%, the implantation rate was 18.5%. Biochemical, clinical and ongoing pregnancy rates per attempt were 47% (62/132), 41% (54/132), and 36% (47/132). Biochemical, clinical and ongoing pregnancy rates per transfer were 50% (62/124), 43.5% (54/124), and 38.% (47/124). The mean treatment duration (number of injections) with ganirelix was 3.5 (SD 1,2) days, the mean duration of rec-FSH (Puregon®) treatment was 9.07 (SD 1.6) daysand the mean total amount of rec-FSH (Puregon®) administered was 2068.18 IU (SD 555) IU. The incidence of moderate ovarian hyperstimulation syndrome was 4.5% and 5 discontinuations because of moderate OHSS (3.7%) were reported. Conclusion: The use of ganirelix (Orgalutran®) in a flexible regimen in combination with follitropin-beta (Puregon®) is a short, simple and safe treatment regimen, optimizes patient convenience and results in a good clinical outcome.