Efficacy and safety of highly purified menotropin versus recombinant follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection cycles: a randomized, comparative trial.
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.


METHODS
Multinational, open label, randomized, parallel group, comparative phase III trial.


METHODS
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).


METHODS
A total of 781 women were enrolled between May 1999 and November 2000.


METHODS
In the all-patients-treated population, 373 patients received HP-hMG and 354 received recombinant FSH. A long protocol GnRH agonist regimen was used.


METHODS
The primary end point was ongoing pregnancy rate following one IVF/ICSI treatment cycle. Safety was assessed as a secondary end point.


RESULTS
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.


CONCLUSIONS
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.
D000328:Adult; D004958:Estradiol / Q000097:blood; D005260:Female; D005306:Fertilization / Q000502:physiology; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000627:therapeutic use*; D006801:Humans; D007247:Infertility, Female / Q000209:etiology; D007248:Infertility, Male / Q000209:etiology; D008297:Male; D009074:Melanocyte-Stimulating Hormones / Q000627:therapeutic use*; D010062:Ovulation Induction; D011247:Pregnancy; D011256:Pregnancy Outcome; D011994:Recombinant Proteins / Q000627:therapeutic use; D020554:Sperm Injections, Intracytoplasmic; D016896:Treatment Outcome
D011994:Recombinant Proteins; D004958:Estradiol; D005640:Follicle Stimulating Hormone; D009074:Melanocyte-Stimulating Hormones