Basal Androgens and LH Needing for Ovarian Stimulation for in Vitro Fertilization
NCT ID: NCT01563809
Last Updated: 2015-04-22
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
PHASE3
400 participants
INTERVENTIONAL
2008-12-31
2010-12-31
Brief Summary
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Detailed Description
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* Population: Patients with indication of In Vitro Fertilization (IVF) with the following criteria:
* Protocol: All patients are tested on day 3-5 of cycle for total Testosterone (Te), Dehydroepiandrosetnodione sulphate (DHEAS) and Androstenodione (Δ4). Samples are frozen and stored at -20ºC for later analysis. FSH, LH, E2, PRL and TSH are also determined. All patients follow Controlled Ovarian Stimulation for IVF with a GnRH agonist long protocol. They are randomized to receive recombinant (r) FSH alone (225 IU/day) or r-FSH + r-LH (225+75 IU/day).
* Sample size calculation: To detect a difference from 40 to 60% (Relative risk: 1.50) on pregnancy rate (PR) between patients with low and high androgen levels with respect to the mean of each COS protocol, with a confidence level of 95% (error α=0.05) and 80% of power (error β=0.2), 97 patients per arm were needed. (n=388 patients). Rounding up, 400 patients are to be recruited.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low androgens FSH+LH
Patients with androgens below threshold receiving FSH+LH for ovarian stimulation
FSH+LH
75 IU of LH will be given from stimulation day 1
High androgens FSH+LH
Patients with androgens above threshold receiving FSH+LH for ovarian stimulation
FSH+LH
75 IU of LH will be given from stimulation day 1
High androgens FSH alone
No interventions assigned to this group
Low androgens, FSH alone
No interventions assigned to this group
Interventions
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FSH+LH
75 IU of LH will be given from stimulation day 1
FSH+LH
75 IU of LH will be given from stimulation day 1
Eligibility Criteria
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Inclusion Criteria
* Regular cycle (25-35 days)
* Age 18 - 42
* BMI: 18-29.9
Exclusion Criteria
* Low response background (\< 5 oocytes)
* Recurrent pregnancy loss
* Preimplantational genetic diagnosis indication
* Any systemic, metabolic or endocrinological disorder.
18 Years
42 Years
FEMALE
Yes
Sponsors
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Instituto Valenciano de Infertilidad, IVI VALENCIA
OTHER
Responsible Party
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Ernesto Bosch
Medical Director IVI Valencia
Locations
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IVI Valencia
Valencia, , Spain
Countries
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Other Identifiers
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0711-E-39-EB
Identifier Type: -
Identifier Source: org_study_id
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