Objective: To demonstrate that highly purified human menopausal gonadotropin (HP-hMG) is as efficient and safe as recombinant FSH in females undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment cycles.
Design: Multinational, open label, randomized, parallel group, comparative phase III trial.
Setting: In 22 centers across six countries; Belgium (1 center), Germany (6 centers), Israel (6 centers), The Netherlands (2 centers), Switzerland (1 center) and the United Kingdom (6 centers).
Patient(s): A total of 781 women were enrolled between May 1999 and November 2000.
Intervention(s): In the all-patients-treated population, 373 patients received HP-hMG and 354 received recombinant FSH. A long protocol GnRH agonist regimen was used.
Main outcome measure(s): The primary end point was ongoing pregnancy rate following one IVF/ICSI treatment cycle. Safety was assessed as a secondary end point.
Result(s): Ongoing pregnancy rates 10 weeks after ovum pickup in the per-protocol population were 25% (n = 85/344) in the HP-hMG group and 22% (n = 71/317) in the recombinant FSH group. The incidence of ovarian hyperstimulation syndrome, miscarriage, adverse events, and injection site reactions (tolerability) were similar in both treatment groups.
Conclusion(s): We found HP-hMG to be as effective as recombinant FSH in terms of ongoing clinical pregnancy. Both treatments have a similar safety/tolerability profile.