NCT01915186

Brief Summary

The aim of the study is to evaluate the effect of DHEA supplement on ovarian reserve markers, ovarian response to gonadotrophins and cycle outcomes in patients with normal and poor ovarian reserve. Study Hypotheses:

  1. 1.DHEA supplementation would improve markers of ovarian reserve and ovarian response to low dose FSH stimulation in both normal and poor responders
  2. 2.DHEA supplementation would improve IVF cycle outcomes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

December 20, 2013

Status Verified

December 1, 2013

Enrollment Period

2.3 years

First QC Date

July 31, 2013

Last Update Submit

December 19, 2013

Conditions

Female Infertility Due to Diminished Ovarian Reserve

Keywords

DHEAPoor ovarian reserveNormal ovarian reserveIn vitro fertilization treatmentOvarian responsePregnancy outcomes

Outcome Measures

Primary Outcomes (1)

  • Antral follicle count

    Compare the changes in antral follicle count after 12 weeks of DHEA supplementation prior to IVF treatment between the treatment and placebo groups

    after 12 weeks of DHEA

Secondary Outcomes (1)

  • Change in Follicular stimulating hormone (FSH) and anti-Mullerian Hormone (AMH) following DHEA supplementation; post stimulation estradiol level and number of follicles > 10mm, IVF outcomes, hormonal profile of follicular fluid

    after 12 weeks of DHEA

Study Arms (2)

Dihydroepiandrosterone (DHEA)

EXPERIMENTAL

DHEA 25mg 3 times a day for 12 weeks

Dietary Supplement: Dihydroepiandrosterone (DHEA)

Placebo

PLACEBO COMPARATOR

Matched placebo capsules are given 3 times a day for 12 weeks

Interventions

Dihydroepiandrosterone (DHEA)DIETARY_SUPPLEMENT

DHEA capsules are given at 25mg 3 times a day for 12 weeks

Also known as: DHEA (GNC)
Dihydroepiandrosterone (DHEA)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Indicated for IVF treatment according to our standard department protocol
  • Age \< 40
  • Regular menstrual cycles (21-35 days with \</= 4 days inter-cycle variation)
  • AFC not more than 15

You may not qualify if:

  • Previous chemotherapy or pelvic irradiation
  • Polycystic ovarian syndrome or polycystic ovaries
  • On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (2)

  • Gleicher N, Barad DH. Dehydroepiandrosterone (DHEA) supplementation in diminished ovarian reserve (DOR). Reprod Biol Endocrinol. 2011 May 17;9:67. doi: 10.1186/1477-7827-9-67.

    PMID: 21586137BACKGROUND

  • Yeung TW, Chai J, Li RH, Lee VC, Ho PC, Ng EH. A randomized, controlled, pilot trial on the effect of dehydroepiandrosterone on ovarian response markers, ovarian response, and in vitro fertilization outcomes in poor responders. Fertil Steril. 2014 Jul;102(1):108-115.e1. doi: 10.1016/j.fertnstert.2014.03.044. Epub 2014 May 3.

    PMID: 24796766DERIVED

MeSH Terms

Interventions

Dehydroepiandrosterone

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 2, 2013

Study Start

October 1, 2010

Primary Completion

January 1, 2013

Study Completion

September 1, 2013

Last Updated

December 20, 2013

Record last verified: 2013-12

Locations

HK(1)