Study Stopped
Failure to recruit designed nuimebrt of subjects
Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility
DHEAFert
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).
1 other identifier
interventional
35
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 31, 2008
CompletedFirst Posted
Study publicly available on registry
April 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedSeptember 30, 2015
September 1, 2015
6 years
March 31, 2008
September 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live Birth
24 months
Secondary Outcomes (3)
Endocrine effects
12 months
Androgen side effects
12 months
Clinical Pregnancy
12 months
Study Arms (2)
DHEA
EXPERIMENTALDehydroepiandrosterone (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.
Placebo
PLACEBO COMPARATORBlinded placebo
Interventions
Eligibility Criteria
You may qualify if:
- \>= 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Human Reproduction
New York, New York, 10021, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Barad, MD, MS
Center for Human Reproduction
- STUDY CHAIR
Norbert Gleicher, MD
Center for Human Reproduction
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2008
First Posted
April 2, 2008
Study Start
March 1, 2008
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
September 30, 2015
Record last verified: 2015-09