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

September 18, 2014 updated by: Fady I. Sharara, M.D, Virginia Center for Reproductive Medicine
This prospective study evaluates the effect of DHEA supplementation on markers of ovarian reserve in women with diminished ovarian reserve.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Reston, Virginia, United States, 20190
        • Virginia Center for Reproductive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • infertile women with diminished ovarian reserve

Exclusion Criteria:

  • women > 45

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dehydroepiandrosterone
infertile women with low anti mullerian hormone levels
DHEA supplementation 25 mg tid for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: 3 years
Live birth rate will be monitored for women who took DHEA supplementation
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of oocytes
Time Frame: 3 years
Number of retrieved oocytes for patients undergoing IVF will be monitored along with ovarian response
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fady I Sharara, M.D, Virginia Center for Reproductive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 24, 2010

First Posted (Estimate)

May 25, 2010

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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