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

This study has been terminated.
(Failure to recruit designed nuimebrt of subjects)
Sponsor:
Information provided by (Responsible Party):
David H. Barad, Center for Human Reproduction
ClinicalTrials.gov Identifier:
NCT00650754
First received: March 31, 2008
Last updated: June 29, 2014
Last verified: June 2014

March 31, 2008
June 29, 2014
March 2008
March 2014   (final data collection date for primary outcome measure)
Live Birth [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00650754 on ClinicalTrials.gov Archive Site
  • Endocrine effects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Androgen side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Clinical Pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility
A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Normal Hysterosalpingogram and Normal Semen Analysis and Evidence of Premature Ovarian Aging (POA).

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).

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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Primary Ovarian Insufficiency
  • Unexplained Infertility
Dietary Supplement: Dehydroepiandrosterone
25 mg PO TID
Other Name: DHEA
  • 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.
    Intervention: Dietary Supplement: Dehydroepiandrosterone
  • Placebo Comparator: Placebo
    Blinded placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
March 2014
March 2014   (final data collection date for primary outcome measure)

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:

  • 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
Female
21 Years to 37 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00650754
CHR2008 1.0
No
David H. Barad, Center for Human Reproduction
Center for Human Reproduction
Not Provided
Principal Investigator: David Barad, MD, MS Center for Human Reproduction
Study Chair: Norbert Gleicher, MD Center for Human Reproduction
Center for Human Reproduction
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP