A comparison of the efficacy and tolerability of two recombinant human follicle-stimulating hormone preparations in patients undergoing in vitro fertilization-embryo transfer

Objective: To compare the efficacy and tolerability of two recombinant huma n FSH (r-hFSH) preparations, follitropin-alpha (Gonal-F; Ares Serono, Genev a, Switzerland) and follitropin-beta (Puregon;Organon, Oss, the Netherlands ), for superovulation in patients undergoing IVF-ET. Design: Randomized, parallel-group, assessor-blind, single-center trial. Setting: Outpatient tertiary referral center for assisted reproductive tech niques. Patient(s): Forty-four infertile women undergoing IVF-ET. Intervention(s): After down-regulation with buserelin acetate, patients wer e randomized to receive follitropin-alpha or follitropin-beta, 150 IU/d for 6 days; after that, dosages were adjusted according to the ovarian respons e. Main Outcome Measure(s): Cumulative dose of r-hFSH; duration of r-hFSPI tre atment; number of follicles of greater than or equal to 11 mm and of 14 mm on day 7 of r-hFSPI treatment and on the day of hCG administration; number of oocytes retrieved; number of viable embryos; and number of pregnancies ( biochemical, ectopic, miscarried) and clinical pregnancies. Result(s): There were no statistically significant differences in any effic acy measures between the two preparations. The incidence of systemic advers e events was comparable in the two groups. Local reactions at the inject-io n site were significantly more common and more severe with follitropin-beta than with follitropin-alpha Conclusion(s): Follitropin-alpha and follitropin-beta have comparable effic acy in patients undergoing IVF-ET. Fertil Steril(R) 2000;73:114-6. (C)1999 by American Society for Reproductive Medicine.