Recombinant Follicle Stimulating Hormone (FSH) (Gonal-f®): Use in Ovulation Induction
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
This is an open-label, prospective, randomized, controlled, multicentric, multinational,
phase IV study to evaluate the use of Gonal-f in inducing ovulation in female subjects with
chronic anovulation. It has been observed that conventional high dose set up regimen of
gonadotropin and human chorionic gonadotropin (hCG) is effective in anovulatory subjects in
terms of overall pregnancy rates. However, development of multiple follicles leading to
multiple pregnancy and/or ovarian hyperstimulation syndrome (OHSS) is the major complications
associated with this high dose set up. Chronic low-dose (CLD) protocols of follicle
stimulating hormone (FSH), aimed at finding the threshold amount of FSH necessary to promote
monofolliculogenesis, have been found to be successful in reducing the rate of OHSS almost to
nil and the rate of multiple pregnancies to a minimum. This post-marketing study will
investigate tailoring of recombinant follicle stimulating hormone (r-FSH) in a large
population (N=310) of subjects from a region (North Africa/Middle East) that has not been
included in previous studies of ovulation induction in subjects with chronic anovulation. The
study aims to increase current knowledge of the efficacy and safety of Gonal-f, and provide
fertility physicians with experience in Gonal-f treatment in anovulatory infertility, thereby
contributing to the development of FSH dosing guidelines for ovulation induction by defining
the optimal CLD and Low dose (LD) regimens.
Phase:
Phase 4
Details
Lead Sponsor:
Merck KGaA Merck KGaA, Darmstadt, Germany
Collaborator:
Merck Serono Middle East FZ-LLC, United Arab Emirates, an affiliate of Merck KGaA, Darmstadt, Germany