NCT01129830

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

4.7 years

First QC Date

May 19, 2010

Last Update Submit

September 18, 2014

Conditions

Infertility

Keywords

ovarian reserveFSHanti-mullerian hormoneestradioloocyteIVFembryo transfer

Outcome Measures

Primary Outcomes (1)

  • live birth rate

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

    3 years

Secondary Outcomes (1)

  • number of oocytes

    3 years

Study Arms (1)

Dehydroepiandrosterone

OTHER

infertile women with low anti mullerian hormone levels

Dietary Supplement: dehydroepiandrosterone

Interventions

dehydroepiandrosteroneDIETARY_SUPPLEMENT

DHEA supplementation 25 mg tid for 3 months

Dehydroepiandrosterone

Eligibility Criteria

Age21 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • infertile women with diminished ovarian reserve

You may not qualify if:

  • women \> 45

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Center for Reproductive Medicine

Reston, Virginia, 20190, United States

Location

Related Publications (1)

  • 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.

    PMID: 18071895BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-KetosteroidsKetosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Fady I Sharara, M.D

    Virginia Center for Reproductive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 25, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 22, 2014

Record last verified: 2014-09

Locations

US(1)