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

This study has been terminated.
(Suboptimal recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01129830
First Posted: May 25, 2010
Last Update Posted: September 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine:

Primary Outcome Measures:
  • live birth rate [ Time Frame: 3 years ]
    Live birth rate will be monitored for women who took DHEA supplementation


Secondary Outcome Measures:
  • number of oocytes [ Time Frame: 3 years ]
    Number of retrieved oocytes for patients undergoing IVF will be monitored along with ovarian response


Enrollment: 200
Study Start Date: January 2010
Study Completion Date: September 2014
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infertile women with diminished ovarian reserve

Exclusion Criteria:

  • women > 45
  Contacts and Locations
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): NCT01129830


Locations
United States, Virginia
Virginia Center for Reproductive Medicine
Reston, Virginia, United States, 20190
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
First Submitted: May 19, 2010
First Posted: May 25, 2010
Last Update Posted: September 22, 2014
Last Verified: September 2014

Keywords provided by Fady I. Sharara, M.D, 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