Clinical trial NCT01223079: Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Outcome During r-hFSH Stimulation
Outcome During r-hFSH and r-hLH Stimulation
Keywords: r-hFSH
r-hLH
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Safety and efficacy of r-hFSH protocol
timeFrame: 6 months
measure: Safety and efficacy of r-hFSH + r-hLH protocol
timeFrame: 6 months
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: 6 months
measure: Quality of embryos obtained
timeFrame: 6 months
measure: Incidences of ovarian hyperstimulation syndrome
timeFrame: 6 months
measure: Quality of oocytes obtained
timeFrame: 6 months
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Reproductive Medicine Assoicates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Richard T Scott, MD
role: PRINCIPAL_INVESTIGATOR
References: