- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01129830
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
Intervention / Treatment
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VCRM 3
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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