Basal Androgens and LH Needing for Ovarian Stimulation for in Vitro Fertilization

Study Overview
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Brief Summary
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Basing the investigators study on the evidence that basal serum androgens decrease with age, the investigators hypothesize that women with serum androgens below a certain level could be the population obtaining a benefit of Luteinizing Hormone (LH) supplementation. The objective of the present study is to explore the relationship between basal serum androgen levels and the need of LH for Controlled Ovarian Stimulation (COS) in IVF.

Detailed Description
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Design: Single centre, open label, randomized controlled trial. 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.

Official Title
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The Relationship Between Basal Androgen Levels and the Needing of LH for Controlled Ovarian Stimulation for in Vitro Fertilization

Conditions
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Infertility

Intervention / Treatment
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* Drug: FSH+LH
* Drug: FSH+LH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1st-2nd IVF cycle Regular cycle (25-35 days) Age 18 - 42 BMI: 18-29.9 Exclusion Criteria: LH:FSH > 2 Low response background (< 5 oocytes) Recurrent pregnancy loss Preimplantational genetic diagnosis indication Any systemic, metabolic or endocrinological disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low androgens FSH+LH<br>Patients with androgens below threshold receiving FSH+LH for ovarian stimulation | Drug: FSH+LH<br>* 75 IU of LH will be given from stimulation day 1<br>|
| Active Comparator: High androgens FSH+LH<br>Patients with androgens above threshold receiving FSH+LH for ovarian stimulation | Drug: FSH+LH<br>* 75 IU of LH will be given from stimulation day 1<br>|
| No Intervention: High androgens FSH alone<br> | |
| No Intervention: Low androgens, FSH alone<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rate | Use of rec LH supplementation for controlled ovarian stimulation for IVF | 45 days |