NCT01223079

Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)

Use of r-hLH (Luveris) Late Follicular Phase for Controlled Ovarian Stimulation (COS) in Donor Patients Previously Treated With r-hFSH (Gonal F)in a Long Luteal Downregulated Cycle With GnRH Agonist. A Cross-over Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Reproductive Medicine Associates of New Jersey · Academic / Other
• Sex: Female
• Age: 21 Years – 32 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late follicular phase of young women undergoing controlled ovarian stimulation for oocyte donation.

Detailed description

While the role of FSH is considered the fundamental driver of folliculogenesis, the role of LH in this process is more controversial. FSH is associated with stimulating growth and recruitment of follicles while LH is associated with the selection of dominant follicles destined for ovulation. We will use an open, prospective, cross-over study to compare the safety and efficacy of two different treatment protocols for controlled ovarian stimulation in egg donors. 20 participants will undergo two cycles of stimulation. The first one will be with r-hFSH though the cycle and the second with r-hFSH then r-hLH. The participants will have 1 month rest cycle between the treatment cycles. r-hFSH doses will be adjusted according to patient response. r-hLH dosing will begin when there are 2 follicles greater than or equal to 14mm in diameter. The does will be 300IU/day and continue until the day of r-hCG administration.

Conditions

• Outcome During r-hFSH Stimulation
• Outcome During r-hFSH and r-hLH Stimulation

Interventions

Type	Name	Description
DRUG	r-hFSH	r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response
DRUG	r-hFSH and r-hLH	Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-12-01
• Completion: 2008-12-01
• First posted: 2010-10-18
• Last updated: 2013-03-05

Locations

1 site across 1 country: United States