Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)
NCT ID: NCT01223079
Last Updated: 2013-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2005-12-31
2008-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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r-hFSH (Gonal F)
Patients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration.
r-hFSH
r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response
r-hFSH (Gonal F) and r-hLH (Luveris)
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.
r-hFSH and r-hLH
Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.
Interventions
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r-hFSH
r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response
r-hFSH and r-hLH
Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
32 Years
FEMALE
Yes
Sponsors
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Reproductive Medicine Associates of New Jersey
OTHER
Responsible Party
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Principal Investigators
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Richard T Scott, MD
Role: PRINCIPAL_INVESTIGATOR
Reproductive Medicine Associates of New Jersey
Locations
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Reproductive Medicine Assoicates of New Jersey
Morristown, New Jersey, United States
Countries
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Other Identifiers
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20052361
Identifier Type: -
Identifier Source: org_study_id
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