Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF) (DHEAFert2)

This study has been terminated.
(Lack of recruitment.)
Sponsor:
Information provided by (Responsible Party):
David H. Barad, Center for Human Reproduction
ClinicalTrials.gov Identifier:
NCT00948857
First received: July 28, 2009
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

The experimental focus of this project is on the interaction of DHEA treatment on pregnancy in women with open tubes, fertile male partners and evidence of premature ovarian failure.


Condition Intervention Phase
Premature Ovarian Failure
Dietary Supplement: Dehydroepiandrosterone
Dietary Supplement: Placebo
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 Premature Ovarian Failure (POF).

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 ]
  • Live Birth [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Live Birth outcome compared between DHEA active treatment and Placebo


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 ]

Enrollment: 5
Study Start Date: June 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DHEA active treatment
Dehydroepiandrosterone 25 mg tid po
Dietary Supplement: Dehydroepiandrosterone
25 mg PO TID
Other Name: DHEA
Placebo Comparator: DHEA Placebo
Blinded placebo
Dietary Supplement: Placebo
Blinded placebo

Detailed Description:

Recruitment:

  • New patients presenting for Donor egg cycles
  • Possible print, magazine or Radio advertisement

Experimental plan:

  1. Informed consent
  2. Baseline studies

    • Antral follicle counts
    • Serum FSH, LH, E2, Prog, DHEA, DHEAS, testosterone, AMH, Fragile X
  3. Randomization

    • 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 treatment
    • Compare antral follicle counts across cycles between groups
    • Compare possible androgen related effects
    • Power considerations:
    • Power assumptions: alpha 0.05; 80% power

Spontaneous Pregnancy rate for POF is less than 1% per 3 months Intervention will improve pregnancy rate to 10% per 3 months. Patients will be treated for 3 cycles. Require 100 patients to complete treatment in each group. Allow for 20% dropout will need 120 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 3 months and possible natural continued loss of fertility
  • Informed consent issues
  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • >= 1 year of infertility
  • >21 and <40 years old
  • Normal HSG
  • Normal Semen analysis (Count >= 20 million/ motility > 50%/ Kruger morph > 14%.
  • Absent menses
  • Willingness to sign informed consent for study randomization
  • Willingness to participate in 3 months of treatment.

Exclusion Criteria:

  • Abnormal semen analysis
  • Abnormal HSG
  • 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 three months of this trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948857

Locations
United States, New York
Center for Human Reproduction
New York, New York, United States, 10021
Sponsors and Collaborators
David H. Barad
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: NCT00948857     History of Changes
Other Study ID Numbers: 092508-01
Study First Received: July 28, 2009
Results First Received: August 2, 2012
Last Updated: September 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Center for Human Reproduction:
DHEA
POF
Pregnancy
Ovarian Failure
Otherwise Unexplained infertility
Ovarian aging

Additional relevant MeSH terms:
Menopause, Premature
Primary Ovarian Insufficiency
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014