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

This study is currently recruiting participants.
Verified August 2012 by Center for Human Reproduction
Sponsor:
Information provided by (Responsible Party):
David H. Barad, Center for Human Reproduction
ClinicalTrials.gov Identifier:
NCT00650754
First received: March 31, 2008
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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).


Condition Intervention Phase
Ovarian Aging
Premature Ovarian Aging
Unexplained Infertility
Dietary Supplement: Dehydroepiandrosterone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Center for Human Reproduction:

Primary Outcome Measures:
  • Live Birth [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 220
Study Start Date: March 2008
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
25 mg PO TID
Other Name: DHEA
Placebo Comparator: Placebo
Blinded placebo

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
  Eligibility

Ages Eligible for Study:   21 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650754

Contacts
Contact: David Barad, MD, MS 212 994-4400 dbarad@theCHR.com
Contact: Jolanta Tapper 212 994-4400 jtapper@theCHR.com

Locations
United States, New York
Center for Human Reproduction Recruiting
New York, New York, United States, 10021
Contact: Jolanta Tapper    212-994-4400    jtapper@theCHR.com   
Contact: Susan    212 994-4400    jgu@theCHR.com   
Principal Investigator: David Barad, MD, MS         
Sub-Investigator: Norbert Gleicher, MD         
Sponsors and Collaborators
Center for Human Reproduction
Investigators
Principal Investigator: David Barad, MD, MS Center for Human Reproduction
Study Chair: Norbert Gleicher, MD Center for Human Reproduction
  More Information

Additional Information:
No publications provided

Responsible Party: David H. Barad, Director of Clinical Research, Center for Human Reproduction
ClinicalTrials.gov Identifier: NCT00650754     History of Changes
Other Study ID Numbers: CHR2008 1.0
Study First Received: March 31, 2008
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Center for Human Reproduction:
DHEA
Pregnancy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014