Clinical assessment of recombinant human follicle-stimulating hormone in stimulating ovarian follicular development before in vitro fertilization. Recombinant Human FSH Study Group.

OBJECTIVE: To compare the efficacy and the safety of recombinant human FSH (hFSH) with urinary hFSH for stimulating follicular development in women undergoing IVF-ET. DESIGN: Multicenter, prospective, randomized, open, parallel group, clinical study. SETTING: Eight European academic IVF units and one private IVF unit. PATIENTS: Infertile female patients aged 18 to 38 years suffering from tubal disease, mild endometriosis, or unexplained infertility. INTERVENTIONS: Pretreatment with buserelin acetate was followed by recombinant or urinary hFSH treatment started at an initial dose of 225 IU FSH/d. Dose adjustment was allowed after 5 days of FSH. After administration of hCG, a standard IVF-ET procedure was performed. MAIN OUTCOME MEASURES: Follicular development, oocyte retrieval, fertilized oocytes, duration and dose of FSH, and pregnancy. The hypothesis formulated before the study was that no difference was expected between the two FSH preparations. RESULTS: Sixty patients were treated with recombinant hFSH and 63 with urinary hFSH. The mean number (+/- SD) of growing follicles (mean diameter > 10 mm) was 10.3 +/- 4.9 and 11.2 +/- 5.2, of follicles (mean diameter > 14 mm) was 7.8 +/- 3.6 and 9.2 +/- 4.5, of retrieved oocytes was 9.3 +/- 5.0 and 10.7 +/- 5.3, and of fertilized oocytes was 5.6 +/- 3.8 and 6.5 +/- 4.3, for recombinant and urinary hFSH, respectively. The duration of FSH treatment was 9.9 +/- 2.3 and 9.4 +/- 1.8 days and the average total dose was 2270 +/- 714 and 2095 +/- 591 IU of FSH, for recombinant and urinary hFSH, respectively. Thirteen pregnancies were recorded in the recombinant hFSH group and 11 in the urinary hFSH group. Nine patients delivered 13 live infants in the recombinant hFSH group and eight delivered 13 live infants in the urinary hFSH group. In terms of safety, no difference was recorded between the groups and no anti-FSH antibodies were found in any of the patients. CONCLUSIONS: This clinical study shows that recombinant hFSH is as safe and effective as urinary hFSH in stimulating ovarian follicular development.