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

Reproductive Medicine Associates of New Jersey20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

r-hFSHDRUG

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

r-hFSH and r-hLHDRUG

Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 32 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Reproductive Medicine Assoicates of New Jersey

Morristown, New Jersey, United States

Outcomes

Primary Outcomes

Safety and efficacy of r-hFSH protocol

Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.

Time frame: 6 months

Safety and efficacy of r-hFSH + r-hLH protocol

Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.

Time frame: 6 months

Secondary Outcomes

Number of oocytes retrieved

Evaluation of the number of oocytes obtained as a function of stimulation protocol.

Time frame: 6 months

Quality of embryos obtained

Evaluation of pregnancy rates (clinical and ongoing), delivery rates, multiple pregnancy rates and the number of cancelled cycles.

Time frame: 6 months

Incidences of ovarian hyperstimulation syndrome

Evaluation of the potential adverse effects associated with ovarian stimulation

Time frame: 6 months

Quality of oocytes obtained

Evaluation of the quality of oocytes obtained as a function of stimulation protocol.

Time frame: 6 months

Data from ClinicalTrials.gov

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