OBJECTIVE: To assess ongoing pregnancy rates (PRs) in IVF after treatment with recombinant FSH (follitropin beta, Puregon; NV Organon, Oss, The Netherlands) as compared with urinary gonadotropins. DESIGN: A combined analysis of three prospective, multicenter, randomized, comparative trials. SETTING:Twenty-five IVF centers in 13 countries. PATIENT(S): Six hundred ninety-seven infertile women receivingrecombinant FSHand 463 women receiving hMG or urinary FSH and undergoing one cycle of controlled ovarian hyperstimulation and IVF-ET. INTERVENTION(S): A center-based and study-based analysis weighing the treatment differences in individual centers and studies, respectively. MAIN OUTCOME MEASURES(S): Pregnancy rate at least 12 weeks after ET per started cycle. RESULTS(S): In the center-based analysis, the ongoing PR was 22.9% for recombinant FSH and 17.9% for urinary gonadotropins. The 5.0% treatment difference (95% confidence interval [CI], 0.2% to 9.7%) was significant. When the results of the cryoprogram were included, the treatment difference increased to 6.4% (95% CI, 1.4% to 11.3%). Also in the study-based analysis, significantly higher PRs were seen after follitropin beta treatment. CONCLUSION(S): Follitropin beta (Puregon) used for controlled ovarian hyperstimulation in IVF yields significantly higher PRs compared with urinary gonadotropins.
RCT Entities:
OBJECTIVE: To assess ongoing pregnancy rates (PRs) in IVF after treatment with recombinant FSH (follitropin beta, Puregon; NV Organon, Oss, The Netherlands) as compared with urinary gonadotropins. DESIGN: A combined analysis of three prospective, multicenter, randomized, comparative trials. SETTING: Twenty-five IVF centers in 13 countries. PATIENT(S): Six hundred ninety-seven infertile women receiving recombinant FSH and 463 women receiving hMG or urinary FSH and undergoing one cycle of controlled ovarian hyperstimulation and IVF-ET. INTERVENTION(S): A center-based and study-based analysis weighing the treatment differences in individual centers and studies, respectively. MAIN OUTCOME MEASURES(S): Pregnancy rate at least 12 weeks after ET per started cycle. RESULTS(S): In the center-based analysis, the ongoing PR was 22.9% for recombinant FSH and 17.9% for urinary gonadotropins. The 5.0% treatment difference (95% confidence interval [CI], 0.2% to 9.7%) was significant. When the results of the cryoprogram were included, the treatment difference increased to 6.4% (95% CI, 1.4% to 11.3%). Also in the study-based analysis, significantly higher PRs were seen after follitropin beta treatment. CONCLUSION(S): Follitropin beta (Puregon) used for controlled ovarian hyperstimulation in IVF yields significantly higher PRs compared with urinary gonadotropins.
Authors: J Balasch; F Fábregues; M Creus; J Peñarrubia; E Vidal; F Carmona; B Puerto; J A Vanrell Journal: J Assist Reprod Genet Date: 2000-01 Impact factor: 3.412