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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, Spain
ClinicalTrials.gov Identifier:
NCT01563809
First received: March 22, 2012
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Infertility
 Other: No intervention
Drug: FSH+LH
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Relationship Between Basal Androgen Levels and the Needing of LH for Controlled Ovarian Stimulation for in Vitro Fertilization

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Clinical Pregnancy Rate [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    Use of rec LH supplementation for controlled ovarian stimulation for IVF


Enrollment: 400
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low androgens FSH+LH Drug: FSH+LH
Luteinizing Hormone will be administered to this patient
Active Comparator: High androgens FSH+LH Drug: FSH+LH
Luteinizing Hormone will be administered to this patient
No Intervention: High androgens FSH alone Other: No intervention
No Luteinizing Hormone will be administered to this patient
No Intervention: Low androgens, FSH alone Other: No intervention
No Luteinizing Hormone will be administered to this patient

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.
  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563809

Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

No publications provided

Responsible Party: Ernesto Bosch, Medical Director IVI Valencia, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01563809     History of Changes
Other Study ID Numbers: 0711-E-39-EB
Study First Received: March 22, 2012
Last Updated: May 7, 2012
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013