The Effect of DHEA on Markers of Ovarian Reserve in Women... | NCT01129830

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

NCT01129830

Sponsor

Virginia Center for Reproductive Medicine

Status

Terminated

Last Update Posted

Sep 22, 2014Estimated

Enrollment

200Actual

Phase

Early Phase 1

Conditions

Infertility

Interventions

dehydroepiandrosterone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Suboptimal recruitment

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

May 19, 2010

First Submission Date that Met QC Criteria

May 24, 2010

First Posted Date

May 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2014

Last Update Posted Date

Sep 22, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fady I. Sharara, M.D, Medical Director, Virginia Center for Reproductive MedicinePrincipal Investigator

Lead Sponsor

Virginia Center for Reproductive MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dehydroepiandrosterone	Other	infertile women with low anti mullerian hormone levels	Dietary Supplement: dehydroepiandrosterone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dehydroepiandrosterone	Dietary Supplement	DHEA supplementation 25 mg tid for 3 months	Dehydroepiandrosterone

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infertile women with diminished ovarian reserve

Exclusion Criteria:

women > 45

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fady I Sharara, M.D	Virginia Center for Reproductive Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Center for Reproductive Medicine		Reston	Virginia	20190	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18071895	Background	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473