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

  Show Detailed Description

  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
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: 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
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014