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

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ClinicalTrials.gov Identifier: NCT01563809
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Ernesto Bosch, Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief 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.

Condition or disease Intervention/treatment Phase
Infertility Drug: FSH+LH Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Active Comparator: Low androgens FSH+LH
Patients with androgens below threshold receiving FSH+LH for ovarian stimulation
Drug: FSH+LH
75 IU of LH will be given from stimulation day 1
Active Comparator: High androgens FSH+LH
Patients with androgens above threshold receiving FSH+LH for ovarian stimulation
Drug: FSH+LH
75 IU of LH will be given from stimulation day 1
No Intervention: High androgens FSH alone
No Intervention: Low androgens, FSH alone



Primary Outcome Measures :
  1. Clinical Pregnancy Rate [ Time Frame: 45 days ]
    Use of rec LH supplementation for controlled ovarian stimulation for IVF



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563809


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

Responsible Party: Ernesto Bosch, Medical Director IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT01563809     History of Changes
Other Study ID Numbers: 0711-E-39-EB
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Androgens
Ascorbic Acid
Estrogens, Conjugated (USP)
Methyltestosterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents