NCT01339299

Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)

The Endocrine Efficacy of Either Recombinant Luteinizing Hormone (r-LH) or Low Dose Recombinant Human Chorionic Gonadotropin (r-hCG) Supplementation for Recombinant Follicle Stimulating Hormone (r-FSH) Stimulation in Normogonadotrophic Women Undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Therapy Following a Long-term Gonadotropin Releasing Hormone (GnRH) Agonist Down Regulation Protocol

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Regionshospitalet Viborg, Skive · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women.

Conditions

• Controlled Ovarian Stimulation
• Infertility

Interventions

Type	Name	Description
DRUG	recombinant luteinizing hormone (r-LH)	administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
DRUG	recombinant human chorionic gonadotropin (r-hCG)	administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-04-20
• Last updated: 2013-11-27
• Results posted: 2013-11-27

Locations

1 site across 1 country: Denmark