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Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044369
Recruitment Status : Completed
First Posted : August 28, 2002
Last Update Posted : September 4, 2006
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)

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).

Condition or disease Intervention/treatment
Varicocele Male Infertility Hypospermatogenesis Non-Obstructive Azoospermia Procedure: Varicocele repair

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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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00044369

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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
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
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Principal Investigator: Susan H Benoff, PhD North Shore University Hospital
Layout table for additonal information Identifier: NCT00044369    
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):
environmental toxins
male infertility
Additional relevant MeSH terms:
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Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Vascular Diseases
Cardiovascular Diseases