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Trial record 45 of 235 for:    PRASTERONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00948857
Recruitment Status : Terminated (Lack of recruitment.)
First Posted : July 29, 2009
Results First Posted : September 5, 2012
Last Update Posted : September 10, 2012
Information provided by (Responsible Party):
David H. Barad, Center for Human Reproduction

Brief Summary:
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 or disease Intervention/treatment Phase
Premature Ovarian Failure Dietary Supplement: Dehydroepiandrosterone Dietary Supplement: Placebo Phase 2 Phase 3

Detailed Description:


  • 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, 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).
Study Start Date : June 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Live Birth [ Time Frame: 24 months ]
  2. Live Birth [ Time Frame: 9 months ]
    Live Birth outcome compared between DHEA active treatment and Placebo

Secondary Outcome Measures :
  1. Endocrine Effects [ Time Frame: 12 months ]
  2. Androgen Side Effects [ Time Frame: 12 months ]
  3. Clinical Pregnancy [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00948857

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United States, New York
Center for Human Reproduction
New York, New York, United States, 10021
Sponsors and Collaborators
David H. Barad
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Principal Investigator: David Barad, MD, MS Center for Human Reproduction
Study Chair: Norbert Gleicher, MD Center for Human Reproduction

Additional Information:
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Responsible Party: David H. Barad, Director of Clinical Research, Center for Human Reproduction Identifier: NCT00948857     History of Changes
Other Study ID Numbers: 092508-01
First Posted: July 29, 2009    Key Record Dates
Results First Posted: September 5, 2012
Last Update Posted: September 10, 2012
Last Verified: September 2012
Keywords provided by David H. Barad, Center for Human Reproduction:
Ovarian Failure
Otherwise Unexplained infertility
Ovarian aging
Additional relevant MeSH terms:
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Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs