A Trial of Dehydroepiandrosterone (DHEA) Treatment for in Vitro Fertilization (IVF)

This study has been terminated.
(Failure to recruit sufficient participants.)
Sponsor:
Collaborator:
Foundation for Reproductive Medicine
Information provided by:
Center for Human Reproduction
ClinicalTrials.gov Identifier:
NCT00419913
First received: January 7, 2007
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

Our long term goal is to elucidate the role of DHEA on follicular dynamics in the human ovary and to better understand the interaction of DHEA supplementation with other treatments for ovulation induction, especially among older reproductive age women.

The specific hypothesis behind the proposed research is that DHEA is a regulator of follicular dynamics acting in the early pre-gonadotropin dependent stage of initial primordial follicle recruitment and growth.


Condition Intervention Phase
Infertility
Decreased Ovarian Reserve
Dietary Supplement: Dehydroepiandrosterone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Trial of Dehydroepiandrosterone (DHEA) Treatment for Two Months Before Starting Ovulation Induction for in Vitro Fertilization (IVF)

Resource links provided by NLM:


Further study details as provided by Center for Human Reproduction:

Primary Outcome Measures:
  • Clinical Pregnancy per cycle of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Embryos per cycle of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Oocytes per cycle of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Dehydroepiandrosterone (DHEA) 25mg tid
Dietary Supplement: Dehydroepiandrosterone
DHEA 25 mg tid
Other Name: Dehydroepiandrosterone
Placebo Comparator: B Dietary Supplement: Dehydroepiandrosterone
DHEA 25 mg tid
Other Name: Dehydroepiandrosterone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women over the age of 40 and less than 45 years old presenting for IVF treatment.
  • Willingness to sign informed consent for study randomization.
  • Willingness to participate in 2 months pre-IVF treatment.

Exclusion Criteria:

  • Medical condition that would contraindicate pregnancy, ovulation induction or general anesthesia.
  • Family history of significant genetic disease, or factor V Leiden thrombophilia.
  • Inability to present for monitoring visits.
  • Inability to follow medication instruction.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419913

Locations
United States, New York
Center for Human Reproduction
New York, New York, United States, 10021
Austria
Institute fur Reproduktionsmedzin und Endokrinologie
Bregenz, Austria
Sponsors and Collaborators
Center for Human Reproduction
Foundation for Reproductive Medicine
Investigators
Principal Investigator: David Barad, MD Center for Human Reproduction
  More Information

Publications:
Responsible Party: Dr. David H. Barad, Center for Human Reproduction
ClinicalTrials.gov Identifier: NCT00419913     History of Changes
Other Study ID Numbers: CHR2006 1.0
Study First Received: January 7, 2007
Last Updated: March 31, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Center for Human Reproduction:
Ovulation Induction
In vitro Fertilization
Pregnancy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014