Status:
WITHDRAWN
Molecular Markers of Human Sperm Function
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Infertility
Reproduction
Eligibility:
All Genders
19+ years
Brief Summary
Objectives: Male factor infertility is poorly understood and our ability to evaluate the male contribution to a couple's infertility is very limited. The overarching goal of this project is to unders...
Detailed Description
Objectives: Male factor infertility is poorly understood and our ability to evaluate the male contribution to a couple's infertility is very limited. The overarching goal of this project is to unders...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Infertile couples undergoing an ART cycle at DFC in which eggs are retrieved from the female partner. This type of ART cycle comprises approximately 80-90 percent of the ART cycles at DFC.
- Infertile couples undergoing an ART cycle at DFC in which the eggs are retrieved from an anonymous egg donor. Approximately 10-20 percent of the ART cycles at DFC involve anonymous egg donation.
- Willing and able to provide informed consent.
- Age greater than or equal to 18 (both partners in couple). Essentially all infertile couples who enter clinical ART programs at least age 18.
- EXCLUSION CRITERIA:
- Previous completed participation in the study. A complete data set will be obtained from either partner of a couple only once for this study.
- Cancellation of the ART cycle prior to egg retrieval, or no fertilizable eggs retrieved. In this case it would not be possible to determine our primary outcome.
- Age less than 18 (either partner in couple). Because they so rarely experience clinical infertility, we do not expect any couples under age 18 to enter the ART program, so we will not include these as subjects.
- Use of frozen sperm to inseminate eggs. The rationale for this exclusion is that the effect of cryopreservation reagents on PLC zeta activity is unknown, and very few of the ART cycles at DFC utilize donor sperm so we would not be able to control appropriately for this confounder.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00767611
Start Date
October 1 2008
End Date
July 1 2009
Last Update
May 10 2012
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27710