Multicenter, prospective, randomized, investigator blind, controlled clinical trial. Two parallel groups, one receiving the test drug hMG (hMG-IBSA, IBSA Institut Biochimique sa) and the other the reference drug hMG (Menopure, Ferring Pharmaceuticals, Inc.).
Primary Outcome Measures:
- total number of oocytes retrieved 34 - 36 hours after hCG administration.
Secondary Outcome Measures:
- Total dose of hMG (IU); number of days of hMG stimulation and stimulation duration; cancellation rate with reasons; 17β-estradiol (E2) serum concentration; number of follicles >16 mm.
- number of mature oocytes and inseminated oocytes; fertilization rate.
- embryo score; number of transferred embryos; implantation rate, number of transferred embryos; clinical pregnancy rate
- Tolerability evaluation
Estimated Enrollment: |
144 |
Study Start Date: |
May 2005 |
Estimated Study Completion Date: |
March 2009 |
Primary Completion Date: |
May 2008 (Final data collection date for primary outcome measure) |
The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopure, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.