NCT01563809

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	FSH+LH	75 IU of LH will be given from stimulation day 1
DRUG	FSH+LH	75 IU of LH will be given from stimulation day 1

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2012-03-27
• Last updated: 2015-04-22

Locations

1 site across 1 country: Spain