A Trial of Dehydroepiandrosterone (DHEA) Treatment for in Vitro Fertilization (IVF) - Full Text View

Sponsors and Collaborators:	Center for Human Reproduction Foundation for Reproductive Medicine
Information provided by:	Center for Human Reproduction
ClinicalTrials.gov Identifier:	NCT00419913

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 II Phase III

MedlinePlus related topics: Infertility

Drug Information available for: Dehydroepiandrosterone sulfate Prasterone

U.S. FDA Resources

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

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
A: Experimental Dehydroepiandrosterone (DHEA) 25mg tid	Dietary Supplement: Dehydroepiandrosterone DHEA 25 mg tid
B: Placebo Comparator	Dietary Supplement: Dehydroepiandrosterone DHEA 25 mg tid

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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

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:

Barad D, Gleicher N. Effect of dehydroepiandrosterone on oocyte and embryo yields, embryo grade and cell number in IVF. Hum Reprod. 2006 Nov;21(11):2845-9. Epub 2006 Sep 22.

Barad DH, Gleicher N. Increased oocyte production after treatment with dehydroepiandrosterone. Fertil Steril. 2005 Sep;84(3):756.

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

Keywords provided by Center for Human Reproduction:

Ovulation Induction
In vitro Fertilization
Pregnancy

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Dehydroepiandrosterone
Genital Diseases, Male

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009