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

Last updated: April 21, 2015
Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Overall Status: Completed

Phase

3

Condition

Infertility

Treatment

N/A

Clinical Study ID

NCT01563809
0711-E-39-EB
  • Ages 18-42
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1st-2nd IVF cycle

  • Regular cycle (25-35 days)

  • Age 18 - 42

  • BMI: 18-29.9

Exclusion

Exclusion Criteria:

  • LH:FSH > 2

  • Low response background (< 5 oocytes)

  • Recurrent pregnancy loss

  • Preimplantational genetic diagnosis indication

  • Any systemic, metabolic or endocrinological disorder.

Study Design

Total Participants: 400
Study Start date:
December 01, 2008
Estimated Completion Date:
December 31, 2010

Study Description

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.

Connect with a study center

  • IVI Valencia

    Valencia, 46015
    Spain

    Site Not Available

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