Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele
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ClinicalTrials.gov Identifier: NCT00044369 |
Recruitment Status
:
Completed
First Posted
: August 28, 2002
Last Update Posted
: September 4, 2006
|
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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).
Condition or disease | Intervention/treatment |
---|---|
Varicocele Male Infertility Hypospermatogenesis Non-Obstructive Azoospermia | Procedure: Varicocele repair |
Study Type : | Observational |
Enrollment : | 400 participants |
Observational Model: | Defined Population |
Primary Purpose: | Screening |
Time Perspective: | Longitudinal |
Time Perspective: | Prospective |
Official Title: | Increased Testicular Cd2+ & Infertility With Varicocele ( a Varicose Vein in the Scrotum) |
Study Start Date : | May 2000 |
Study Completion Date : | April 2005 |


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Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
- Healthy male with varicocele (grades 2 [palpable] or 3 [visible, palpable]) and no other diagnosed cause for infertility
- Non-smoker
- Actively desiring children but never having initiated a pregnancy
- Female partner having no unresolved fertility issues

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044369
United States, New Jersey | |
University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden | |
Camden, New Jersey, United States, 08103 | |
United States, New York | |
North Shore University Hospital | |
Manhasset, New York, United States, 11030 |
Principal Investigator: | Susan H Benoff, PhD | North Shore University Hospital |
Publications:
ClinicalTrials.gov Identifier: | NCT00044369 History of Changes |
Other Study ID Numbers: |
10496-CP-001 |
First Posted: | August 28, 2002 Key Record Dates |
Last Update Posted: | September 4, 2006 |
Last Verified: | September 2006 |
Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Varicocele environmental toxins male infertility cadmium |
Additional relevant MeSH terms:
Infertility Infertility, Male Azoospermia Varicocele Oligospermia |
Genital Diseases, Male Genital Diseases, Female Vascular Diseases Cardiovascular Diseases |