Comparison of the efficacy and safety of a highly purified human follicle-stimulating hormone (Bravelle™) and recombinant follitropin-β for in vitro fertilization: a prospective, randomized study¹ ☆

Abstract 

Objective: To compare the efficacy and safety of Bravelle s.c., Bravelle i.m., and Follistim s.c. in patients undergoing controlled ovarian hyperstimulation for IVF-ET.

Design: Open-label, randomized, parallel group, multicenter study.

Setting: Eleven academic and private fertility clinics with experience in IVF-ET.

Patient(s): Infertile premenopausal women with regular ovulatory menstrual cycles undergoing IVF-ET.

Intervention(s): Down-regulation with leuprolide acetate followed by up to 12 days of Bravelle s.c. (n = 60), Bravelle i.m. (n = 59), or Follistim s.c. (n = 58); hCG administration, oocyte retrieval, and ET.

Main Outcome Measure(s): Mean number of oocytes retrieved; patients with ET, chemical, clinical and continuing pregnancies; mean peak serum E₂ levels; adverse events and injection site pain scores.

Result(s): There were no significant differences among treatment groups in mean number of oocytes retrieved, peak serum E₂ levels, patients with ET, continuing pregnancies, or live births. There were no significant differences among the treatment groups in the number, nature, or intensity of adverse events. Patients treated with Bravelle s.c. or Bravelle i.m. experienced significantly less injection site pain than patients treated with Follistim s.c.

Conclusion(s): Bravelle s.c. and Bravelle i.m. are comparable in efficacy and safety to Follistim s.c. in patients undergoing controlled ovarian hyperstimulation for IVF-ET.

Keywords:  Bravelle, subcutaneous, intramuscular, highly purified, urofollitropin, follitropin-β, Follistim, human clinical trial, in vitro fertilization, pregnancy

• 1 Commercial product mentioned: Bravelle (urofollitropin for injection, purified), Ferring Pharmaceuticals, Inc., Tarrytown, New York.