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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ernesto Bosch, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT01563809
First received: March 22, 2012
Last updated: April 21, 2015
Last verified: April 2015

March 22, 2012
April 21, 2015
December 2008
December 2010   (final data collection date for primary outcome measure)
Clinical Pregnancy Rate [ Time Frame: 45 days ] [ Designated as safety issue: No ]
Use of rec LH supplementation for controlled ovarian stimulation for IVF
Same as current
Complete list of historical versions of study NCT01563809 on ClinicalTrials.gov Archive Site
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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
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
Drug: FSH+LH
75 IU of LH will be given from stimulation day 1
  • Active Comparator: Low androgens FSH+LH
    Patients with androgens below threshold receiving FSH+LH for ovarian stimulation
    Intervention: Drug: FSH+LH
  • Active Comparator: High androgens FSH+LH
    Patients with androgens above threshold receiving FSH+LH for ovarian stimulation
    Intervention: Drug: FSH+LH
  • No Intervention: High androgens FSH alone
  • No Intervention: Low androgens, FSH alone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 42 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01563809
0711-E-39-EB
No
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Ernesto Bosch, Instituto Valenciano de Infertilidad, IVI VALENCIA
Instituto Valenciano de Infertilidad, IVI VALENCIA
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Not Provided
Instituto Valenciano de Infertilidad, IVI VALENCIA
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP