CLINICAL-ASSESSMENT OF RECOMBINANT HUMAN FOLLICLE-STIMULATING-HORMONEIN STIMULATING OVARIAN FOLLICULAR DEVELOPMENT BEFORE IN-VITRO FERTILIZATION

Objective: To compare the efficacy and the safety of recombinant human FSH (hFSH) with urinary hFSH for stimulating follicular development i n women undergoing IVF-ET. Design: Multicenter, prospective, randomize d, open, parallel group, clinical study. Setting: Eight European acade mic IVF units and one private IVF unit. Patients: Infertile female pat ients aged 18 to 38 years suffering from tubal disease, mild endometri osis, or unexplained infertility. Interventions: Pretreatment with bus erelin acetate was followed by recombinant or urinary hFSH treatment s tarted 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 p rocedure was performed. Main Outcome Measures: Follicular development, oocyte retrieval, fertilized oocytes, duration and dose of FSH, and p regnancy. The hypothesis formulated before the study was that no diffe rence was expected between the two FSH preparations. Results: Sixty pa tients were treated with recombinant hFSH and 63 with urinary hFSH. Th e 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) w as 7.8 +/- 3.6 and 9.2 +/- 4.5, of retrieved oocytes was 9.3 +/- 5.0 a nd 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 tot al dose was 2270 +/- 714 and 2095 +/- 591 IU of FSH, for recombinant a nd urinary hFSH, respectively. Thirteen pregnancies were recorded in t he recombinant hFSH group and 11 in the urinary hFSH group. Nine patie nts delivered 13 live infants in the recombinant hFSH group and eight delivered 13 live infants in the urinary hFSH group. In terms of safet y, no difference was recorded between the groups and no anti-FSH antib odies were found in any of the patients. Conclusions: This clinical st udy shows that recombinant hFSH is as safe and effective as urinary hF SH in stimulating ovarian follicular development.