Status:
COMPLETED
Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)
Lead Sponsor:
Reproductive Medicine Associates of New Jersey
Conditions:
Outcome During r-hFSH Stimulation
Outcome During r-hFSH and r-hLH Stimulation
Eligibility:
FEMALE
21-32 years
Phase:
NA
Brief 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 folli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01223079
Start Date
December 1 2005
End Date
December 1 2008
Last Update
March 5 2013
Active Locations (1)
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1
Reproductive Medicine Assoicates of New Jersey
Morristown, New Jersey, United States, 07960