NCT01112358

Lutropin Alfa in Women at Risk of Poor Response

Lutropin Alfa (Luveris®) in Women at Risk of Poor Response Suppressed With Cetrorelix: an Exploratory Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: Female
• Age: 38 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone \[r-hLH\]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with follitropin alfa (recombinant Follicle-Stimulating Hormone \[r-FSH\]) under Gonadotropin Releasing Hormone (GnRH) antagonist in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), in the number and quality of oocytes, follicular development, fertilization oocyte, embryo quality, and pregnancy rate.

Conditions

• Ovarian Stimulation

Interventions

Type	Name	Description
DRUG	r-FSH	r-FSH will be administered as specified in the arm description.
DRUG	r-hLH	r-hLH will be administered as specified in the arm description.
DRUG	Analogous GnRH antagonist	Analogous GnRH antagonist will be administered as specified in the arm description.
DRUG	r-hCG	r-hCG will be administered as specified in the arm description.
DRUG	Progesterone	Progesterone will be administered as specified in the arm description.

Timeline

• Start date: 2005-12-07
• Primary completion: 2007-01-30
• Completion: 2007-01-30
• First posted: 2010-04-28
• Last updated: 2018-08-28
• Results posted: 2018-07-30

Locations

1 site across 1 country: Spain