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

Not Applicable

Completed

• Conditions: Outcome During r-hFSH Stimulation; Outcome During r-hFSH and r-hLH Stimulation
• Interventions: Drug: r-hFSH; Drug: r-hFSH and r-hLH

• Registration Number: NCT01223079
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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 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 Timeline

• Study Start: 2005-12
• Primary Completion: 2007-12
• Study Completion: 2008-12
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. Age less than or equal to 32 years old
2. BMI<35
3. Eligible for controlled ovarian simulation
4. 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)
5. Meet all requirements for becoming an egg donor
6. Willingness and ability to participate and comply with study protocol for the duration of the study
7. Baseline FSH<11

Exclusion Criteria

1. Clinically significant systemic disease
2. Any contraindication to gonadotropin therapy
3. LH:FSH ratio greater than 3
4. Pregnancy in the past 3 months
5. Any medical condition which, in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug
6. Simultaneous participation in another clinical trial
7. Known active substance abuse, including tobacco and alcohol (>10 cigarettes/day)
8. Refusal or inability to comply with protocol
9. Known poor ovarian response

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
r-hFSH (Gonal F)	r-hFSH	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)	r-hFSH and r-hLH	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.

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of r-hFSH protocol	6 months	Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
Safety and efficacy of r-hFSH + r-hLH protocol	6 months	Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.

Secondary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	6 months	Evaluation of the number of oocytes obtained as a function of stimulation protocol.
Quality of embryos obtained	6 months	Evaluation of pregnancy rates (clinical and ongoing), delivery rates, multiple pregnancy rates and the number of cancelled cycles.
Incidences of ovarian hyperstimulation syndrome	6 months	Evaluation of the potential adverse effects associated with ovarian stimulation
Quality of oocytes obtained	6 months	Evaluation of the quality of oocytes obtained as a function of stimulation protocol.

Trial Locations

Locations (1)

Reproductive Medicine Assoicates of New Jersey; 🇺🇸 Morristown, New Jersey, United States