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
  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
Primary Ovarian Insufficiency
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 ]

Enrollment: 35
Study Start Date: March 2008
Study Completion Date: March 2014
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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Center for Human Reproduction
New York, New York, United States, 10021
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: June 29, 2014
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:
Gonadal Dysgenesis
Infertility
Menopause, Premature
Primary Ovarian Insufficiency
Turner Syndrome
Adnexal Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Chromosome Disorders
Congenital Abnormalities
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Genital Diseases, Male
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Ovarian Diseases
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Urogenital Abnormalities
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014