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 (Menopur, Ferring Pharmaceuticals, Inc.).
The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous hMG preparations (hMG-IBSA, IBSA vs Menopur, Ferring Pharmaceuticals, Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
144
Università degli Studi di Bologna
Bologna, Bologna, Italy
Università degli Studi di Napoli Federico II
Naples, Napoli, Italy
total number of oocytes retrieved 34 - 36 hours after hCG administration.
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
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