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Completed

NCT Number: NCT01563809

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

IVI Valencia

Valencia, 46015, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FSH+LH

Drug

75 IU of LH will be given from stimulation day 1

Primary outcomes

  1. Clinical Pregnancy Rate

    Time frame: 45 days

    Use of rec LH supplementation for controlled ovarian stimulation for IVF

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 27, 2012
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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