Trial | NCT01223079  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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.
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.
Study Started
Dec 31
2005
Primary Completion
Dec 31
2007
Study Completion
Dec 31
2008
Last Update
Mar 05
2013
Estimate

Drug r-hFSH

r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response

  • Other names: Gonal F

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.

  • Other names: r-hFSH, Gonal F, r-hLH, Luveris

r-hFSH (Gonal F) Other

Patients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration.

r-hFSH (Gonal F) and r-hLH (Luveris) Other

Patients will be treated with r-hFSH only until they have 2 follicles greater than or equal to 14mm. Patients will then bring 300IU/day of r-hLH until r-hCG administration.

Criteria 

Inclusion Criteria:

Age less than or equal to 32 years old
BMI<35
Eligible for controlled ovarian simulation
No PCO-type ovaries (PCO by USS image, >2.1 LH;FSH ratio on cycle day 3, insulin resistance, increase of testosterone over free testosterone)
Meet all requirements for becoming an egg donor
Willingness and ability to participate and comply with study protocol for the duration of the study
Baseline FSH<11

Exclusion Criteria:

Clinically significant systemic disease
Any contraindication to gonadotropin therapy
LH:FSH ratio greater than 3
Pregnancy in the past 3 months
Any medical condition which, in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug
Simultaneous participation in another clinical trial
Known active substance abuse, including tobacco and alcohol (>10 cigarettes/day)
Refusal or inability to comply with protocol
Known poor ovarian response
No Results Posted