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| Tracking Information | |||||
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| First Received Date ICMJE | August 27, 2002 | ||||
| Last Updated Date | September 1, 2006 | ||||
| Start Date ICMJE | May 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00044369 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele | ||||
| Official Title ICMJE | Increased Testicular Cd2+ & Infertility With Varicocele ( a Varicose Vein in the Scrotum) | ||||
| Brief Summary | Varicose veins in the scrotum (varicocele) are responsible for >20% of male infertility in the US. Varicocele are associated with decreased sperm number and markedly reduced sperm fertilizing ability. Surgical repair or removal of varicocele restores fertility in only 1/3 of cases. The goal of this study is to identify markers that predict the outcome of variocele correction. This would offer considerable health cost savings. Based on preliminary findings, we will obtain testis biopsies and semen specimens from infertile men with varicocele and prospectively examining the levels of cadmium, a toxic metal, and expression of genes required for normal sperm function. The semen and biopsies will be obtained during clinically dictated procedures. Cadmium and gene expression will be compared with response to varicocele repair (i.e., increased sperm production; pregnancy). |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Screening, Longitudinal, Defined Population, Prospective Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: Varicocele repair | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 400 | ||||
| Completion Date | April 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE |
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| Gender | Male | ||||
| Ages | 21 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00044369 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 10496-CP-001 | ||||
| Study Sponsor ICMJE | National Institute of Environmental Health Sciences (NIEHS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Environmental Health Sciences (NIEHS) | ||||
| Verification Date | September 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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