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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Criteria

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