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

Primary Purpose

Infertility

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
dehydroepiandrosterone
Sponsored by
Virginia Center for Reproductive Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring ovarian reserve, FSH, anti-mullerian hormone, estradiol, oocyte, IVF, embryo transfer

Eligibility Criteria

21 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • infertile women with diminished ovarian reserve

Exclusion Criteria:

  • women > 45

Sites / Locations

  • Virginia Center for Reproductive Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dehydroepiandrosterone

Arm Description

infertile women with low anti mullerian hormone levels

Outcomes

Primary Outcome Measures

live birth rate
Live birth rate will be monitored for women who took DHEA supplementation

Secondary Outcome Measures

number of oocytes
Number of retrieved oocytes for patients undergoing IVF will be monitored along with ovarian response

Full Information

First Posted
May 19, 2010
Last Updated
September 18, 2014
Sponsor
Virginia Center for Reproductive Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01129830
Brief Title
The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve
Official Title
The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Suboptimal recruitment
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Center for Reproductive Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ovarian reserve, FSH, anti-mullerian hormone, estradiol, oocyte, IVF, embryo transfer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dehydroepiandrosterone
Arm Type
Other
Arm Description
infertile women with low anti mullerian hormone levels
Intervention Type
Dietary Supplement
Intervention Name(s)
dehydroepiandrosterone
Intervention Description
DHEA supplementation 25 mg tid for 3 months
Primary Outcome Measure Information:
Title
live birth rate
Description
Live birth rate will be monitored for women who took DHEA supplementation
Time Frame
3 years
Secondary Outcome Measure Information:
Title
number of oocytes
Description
Number of retrieved oocytes for patients undergoing IVF will be monitored along with ovarian response
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infertile women with diminished ovarian reserve Exclusion Criteria: women > 45
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fady I Sharara, M.D
Organizational Affiliation
Virginia Center for Reproductive Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Center for Reproductive Medicine
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18071895
Citation
Barad D, Brill H, Gleicher N. Update on the use of dehydroepiandrosterone supplementation among women with diminished ovarian function. J Assist Reprod Genet. 2007 Dec;24(12):629-34. doi: 10.1007/s10815-007-9178-x. Epub 2007 Dec 11.
Results Reference
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The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve

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