Study Stopped
Failure to recruit sufficient participants.
A Trial of Dehydroepiandrosterone (DHEA) Treatment for in Vitro Fertilization (IVF)
A Randomized Placebo-Controlled Trial of Dehydroepiandrosterone (DHEA) Treatment for Two Months Before Starting Ovulation Induction for in Vitro Fertilization (IVF)
1 other identifier
interventional
8
2 countries
2
Brief Summary
Our long term goal is to elucidate the role of DHEA on follicular dynamics in the human ovary and to better understand the interaction of DHEA supplementation with other treatments for ovulation induction, especially among older reproductive age women. The specific hypothesis behind the proposed research is that DHEA is a regulator of follicular dynamics acting in the early pre-gonadotropin dependent stage of initial primordial follicle recruitment and growth.
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 Jan 2007
Shorter than P25 for phase_2
2 active sites
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
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 7, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedApril 2, 2008
March 1, 2008
6 months
January 7, 2007
March 31, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Pregnancy per cycle of treatment
1 year
Secondary Outcomes (2)
Embryos per cycle of treatment
1 year
Oocytes per cycle of treatment
1 year
Study Arms (2)
A
EXPERIMENTALDehydroepiandrosterone (DHEA) 25mg tid
B
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Women over the age of 40 and less than 45 years old presenting for IVF treatment.
- Willingness to sign informed consent for study randomization.
- Willingness to participate in 2 months pre-IVF treatment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Center for Human Reproduction
New York, New York, 10021, United States
Institute fur Reproduktionsmedzin und Endokrinologie
Bregenz, Austria
Related Publications (2)
Barad D, Gleicher N. Effect of dehydroepiandrosterone on oocyte and embryo yields, embryo grade and cell number in IVF. Hum Reprod. 2006 Nov;21(11):2845-9. doi: 10.1093/humrep/del254. Epub 2006 Sep 22.
PMID: 16997936BACKGROUNDBarad DH, Gleicher N. Increased oocyte production after treatment with dehydroepiandrosterone. Fertil Steril. 2005 Sep;84(3):756. doi: 10.1016/j.fertnstert.2005.02.049.
PMID: 16169414BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Barad, 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
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 7, 2007
First Posted
January 9, 2007
Study Start
January 1, 2007
Primary Completion
July 1, 2007
Study Completion
January 1, 2008
Last Updated
April 2, 2008
Record last verified: 2008-03