drugset / Trial / NCT01110707

A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve

NCT01110707

Phase 2 Completed 131 enrolled Merck KGaA, Darmstadt, Germany
RandomizedParallel-groupOpen-labelTreatment

Summary

This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the follicular phase in subjects undergoing in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of embryos (ET).

Timeline

Start
2005-01-10
Primary completion
2006-11-15
Completion
2006-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant Human Luteinizing Hormone Protein / enzyme biologic 150 iu Subcutaneous
Background Gonal-f Protein / enzyme biologic 300 iu Subcutaneous
Background Gonal-f Protein / enzyme biologic 450 iu Subcutaneous