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

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ClinicalTrials.gov Identifier: NCT00419913
Recruitment Status : Terminated (Failure to recruit sufficient participants.)
First Posted : January 9, 2007
Last Update Posted : April 2, 2008
Sponsor:
Collaborator:
Foundation for Reproductive Medicine
Information provided by:
Center for Human Reproduction

Brief Summary:

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 or disease Intervention/treatment Phase
Infertility Decreased Ovarian Reserve Dietary Supplement: Dehydroepiandrosterone Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : January 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Dehydroepiandrosterone (DHEA) 25mg tid
Dietary Supplement: Dehydroepiandrosterone
DHEA 25 mg tid
Placebo Comparator: B Dietary Supplement: Dehydroepiandrosterone
DHEA 25 mg tid



Primary Outcome Measures :
  1. Clinical Pregnancy per cycle of treatment [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Embryos per cycle of treatment [ Time Frame: 1 year ]
  2. Oocytes per cycle of treatment [ Time Frame: 1 year ]


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Ages Eligible for Study:   40 Years to 45 Years   (Adult)
Sexes 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.

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): 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

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
First Posted: January 9, 2007    Key Record Dates
Last Update Posted: April 2, 2008
Last Verified: March 2008

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