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TerminatedNCT00650754DHEAFertUpdated Sep 30, 2015

Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility

A Phase 2/3 interventional study of Dehydroepiandrosterone and Placebo in Primary Ovarian Insufficiency and Unexplained Infertility, sponsored by Center for Human Reproduction. Terminated at 1 site in United States. Open to female participants aged 21 Years to 37 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-30.

Sponsored by Center for Human Reproduction · Phase 2/3, Interventional, and Treatment

Why this study was terminated
Failure to recruit designed nuimebrt of subjects
Phase
Phase 2/3
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
21 Years to 37 Years
Sex
Female
01

Study summary

The experimental focus of this project is on the interaction of DHEA treatment on pregnancy in women with otherwise unexplained infertility and evidence of premature ovarian aging (POA).

Read the detailed description

Recruitment:

Eligible patients will be recruited by advertising on the web and in newspaper. We will screen women under 38 years old with regular menstrual cycles and more than one year of infertility.

Experimental plan:

  1. Informed consent

  2. Baseline studies

    • Antral follicle counts on Day 2 - 3 of cycle
    • Day 3 Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X

  3. Randomization for pretreatment

    • Group A: DHEA (25 mg three times per day)
    • Group B: Placebo

  4. Monitoring during treatment

    • All participants will have:
    • USG for follicle measurement
    • Repeat serum, FSH, E2, DHEA, DHEAS, testosterone, AMH monthly during treatment.
    • Physical examination
    • Completion of study questionnaire regarding possible androgen effects of treatment

  5. Analysis plan:

    • Primary Outcome
    • Pregnancy
    • Pregnancy rates will be compared using logistic regression with age and pre-treatment AMH as covariates.
    • Secondary Outcomes
    • Endocrine Factors
    • Androgen side effects
    • Primary analysis. We will perform a factorial ANOVA for the two pretreatment factors DHEA and Placebo. Baseline AMH and age as main covariates
    • Secondary analysis.
    • Examine rate of change of estradiol and other endocrine response over the four cycles of pretreatment
    • Compare antral follicle counts across pretreatment cycles between groups
    • Compare possible androgen related effects
    • Power considerations:
    • Power assumptions: alpha 0.05; 80% power
    • Pregnancy rate for unexplained infertility is 2% per cycle.
    • Intervention will improve pregnancy rate to 5% per cycle.
    • Patients will be treated for 8 cycles.
    • Cumulative pregnancy rate for control patients - 13%
    • Cumulative pregnancy rate for Treated patients - 30%
    • Require 91 patients to complete treatment in each group.
    • Allow for 20% dropout ( 91* 1.2) will need 109 patients randomized to each group.
    • Randomization:

Randomization will be by permuted blocks in order to maintain an even distribution among the groups (because of the small numbers of participants)

  • Human subjects issues
  • Potential risks associated with DHEA use
  • Potential risk of delay of treatment for 8 months and possible natural continued loss of fertility
  • Informed consent issues
02

Conditions studied

  • Primary Ovarian Insufficiency
  • Unexplained Infertility

Keywords

  • DHEA
  • Pregnancy
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 35 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Center for Human Reproduction is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 37 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • >= 1 year of infertility
  • \< 38 years old
  • Normal HSG
  • Normal Semen analysis (Count >= 20 million/ motility > 50%/ Kruger morph > 14%.
  • Regular menses
  • Willingness to sign informed consent for study randomization
  • Willingness to participate in 8 months of non-IVF will he him treatment.

Exclusion criteria

Exclusion Criteria:

  • Abnormal semen analysis
  • Abnormal HSG
  • Baseline FSH/E2 within normal age specific criteria
  • Medical condition that would contraindicate pregnancy, ovulation induction or general anesthesia
  • Family history of significant genetic disease, or factor V leiden thrombophilia
  • Inability to present for monitoring visits
  • Inability to follow medication instruction
  • Desire to undergo other fertility treatments before completing eight months of this trial
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    DHEA

    Dehydroepiandrosterone (DHEA) administered at a dose of 25 mg tid po. DHEA is a weak androgen produced naturally by the adrenal in men and women. DHEA production is diminished with increasing age. Peak levels of DHEA occur in the late teenage years.

    Dietary Supplement: Dehydroepiandrosterone

  • Placebo comparator
    Placebo

    Blinded placebo

    Other: Placebo

Interventions

  • Dietary supplementDehydroepiandrosterone

    25 mg PO TID

    Also known as: DHEA

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Live Birth

    Time frame: 24 months

Secondary outcomes

  1. Endocrine effects

    Time frame: 12 months

  2. Androgen side effects

    Time frame: 12 months

  3. Clinical Pregnancy

    Time frame: 12 months

07

Study locations

1 site
  • Center for Human Reproduction
    New York, New York 10021, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00650754
Lead sponsor
Center for Human Reproduction
Responsible party
Sponsor
First posted
Apr 2, 2008
Start date
Mar 2008
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Sep 30, 2015

Study contacts

David Barad, MD, MS
principal investigator · Center for Human Reproduction
Norbert Gleicher, MD
study chair · Center for Human Reproduction

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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