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The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve

This study is currently recruiting participants.
Verified February 2013 by Virginia Center for Reproductive Medicine
Sponsor:
Information provided by (Responsible Party):
Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier:
NCT01129830
First received: May 19, 2010
Last updated: February 10, 2013
Last verified: February 2013
History of Changes
  Purpose

This prospective study evaluates the effect of DHEA supplementation on markers of ovarian reserve in women with diminished ovarian reserve.


Condition Intervention Phase
Infertility
 Dietary Supplement: dehydroepiandrosterone
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve

Resource links provided by NLM:

MedlinePlus related topics: Infertility
Drug Information available for: Prasterone
U.S. FDA Resources

Further study details as provided by Virginia Center for Reproductive Medicine:

Primary Outcome Measures:
  • live birth rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Live birth rate will be monitored for women who took DHEA supplementation


Secondary Outcome Measures:
  • number of oocytes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Number of retrieved oocytes for patients undergoing IVF will be monitored along with ovarian response


Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dehydroepiandrosterone
infertile women with low anti mullerian hormone levels
 Dietary Supplement: dehydroepiandrosterone
DHEA supplementation 25 mg tid for 3 months

Detailed Description:

Ovarian reserve markers, such as FSH, estradiol, AMH, ovarian volume and antral follicle counts will be monitored on DHEA supplementation in a prospective fashion.

  Eligibility

Ages Eligible for Study:   21 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infertile women with diminished ovarian reserve

Exclusion Criteria:

  • women > 45
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129830

Locations
United States, Virginia
Virginia Center for Reproductive Medicine Recruiting
Reston, Virginia, United States, 20190
Contact: Fady I Sharara, M.D     703-437-7722     fsharara@vcrmed.com    
Principal Investigator: Fady I Sharara, M.D            
Sponsors and Collaborators
Virginia Center for Reproductive Medicine
Investigators
Principal Investigator: Fady I Sharara, M.D Virginia Center for Reproductive Medicine
  More Information

Publications:

Responsible Party: Fady I. Sharara, M.D, Medical Director, Virginia Center for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT01129830     History of Changes
Other Study ID Numbers: VCRM 3
Study First Received: May 19, 2010
Last Updated: February 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Center for Reproductive Medicine:
ovarian reserve
FSH
anti-mullerian hormone
estradiol
 oocyte
IVF
embryo transfer

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 May 16, 2013