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

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ClinicalTrials.gov Identifier: NCT00650754
Recruitment Status : Terminated (Failure to recruit designed nuimebrt of subjects)
First Posted : April 2, 2008
Last Update Posted : September 30, 2015
Information provided by (Responsible Party):
Center for Human Reproduction

Brief 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).

Condition or disease Intervention/treatment Phase
Primary Ovarian Insufficiency Unexplained Infertility Dietary Supplement: Dehydroepiandrosterone Other: Placebo Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 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 Normal Hysterosalpingogram and Normal Semen Analysis and Evidence of Premature Ovarian Aging (POA).
Study Start Date : March 2008
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Prasterone
U.S. FDA Resources

Arm Intervention/treatment
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
Other: Placebo

Primary Outcome Measures :
  1. Live Birth [ Time Frame: 24 months ]

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 37 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT00650754

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

Additional Information:
Responsible Party: Center for Human Reproduction
ClinicalTrials.gov Identifier: NCT00650754     History of Changes
Other Study ID Numbers: CHR2008 1.0
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015

Keywords provided by Center for Human Reproduction:

Additional relevant MeSH terms:
Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs