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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: r-hFSH
* Drug: r-hFSH and r-hLH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: r-hFSH (Gonal F)<br>Patients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration. | Drug: r-hFSH<br>* r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response<br>* Other names: Gonal F;|
| Other: r-hFSH (Gonal F) and r-hLH (Luveris)<br>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. | Drug: r-hFSH and r-hLH<br>* Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.<br>* Other names: Luveris;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of r-hFSH protocol | Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients. | 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. | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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r-hFSH, r-hLH