Study Stopped
Lack of recruitment.
Dehydroepiandrosterone (DHEA) Treatment and Premature Ovarian Failure (POF)
DHEAFert2
A Randomized Double Blinded Trail of DHEA Supplementation for Treatment of Couples With Premature Ovarian Failure (POF).
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 28, 2009
CompletedFirst Posted
Study publicly available on registry
July 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
September 5, 2012
CompletedSeptember 10, 2012
September 1, 2012
2.3 years
July 28, 2009
August 2, 2012
September 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Live Birth
24 months
Live Birth
Live Birth outcome compared between DHEA active treatment and Placebo
9 months
Secondary Outcomes (3)
Endocrine Effects
12 months
Androgen Side Effects
12 months
Clinical Pregnancy
12 months
Study Arms (2)
DHEA active treatment
EXPERIMENTALDehydroepiandrosterone 25 mg tid po
DHEA Placebo
PLACEBO COMPARATORBlinded placebo
Interventions
Eligibility Criteria
You may qualify if:
- \>= 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David H. Baradlead
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)
Limitations and Caveats
Termination due to lack of consenting participants.
Results Point of Contact
- Title
- Dr. Norbert Gleicher
- Organization
- Center for Human Reproduction
Study Officials
- PRINCIPAL INVESTIGATOR
David Barad, MD, MS
Center for Human Reproduction
- STUDY CHAIR
Norbert Gleicher, MD
Center for Human Reproduction
Publication Agreements
- PI is Sponsor Employee
- Yes
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 INVESTIGATOR
- PI Title
- Director of Clinical Research
Study Record Dates
First Submitted
July 28, 2009
First Posted
July 29, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
September 10, 2012
Results First Posted
September 5, 2012
Record last verified: 2012-09