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Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele
This study has been completed.
Study NCT00044369   Information provided by National Institute of Environmental Health Sciences (NIEHS)
First Received: August 27, 2002   Last Updated: September 1, 2006   History of Changes

August 27, 2002
September 1, 2006
May 2000
 
 
 
Complete list of historical versions of study NCT00044369 on ClinicalTrials.gov Archive Site
 
 
 
Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele
Increased Testicular Cd2+ & Infertility With Varicocele ( a Varicose Vein in the Scrotum)

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).

 
 
Observational
Screening, Longitudinal, Defined Population, Prospective Study
  • Varicocele
  • Male Infertility
  • Hypospermatogenesis
  • Non-Obstructive Azoospermia
Procedure: Varicocele repair
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
400
April 2005
 
  • 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
Male
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00044369
 
10496-CP-001
National Institute of Environmental Health Sciences (NIEHS)
 
Principal Investigator: Susan H Benoff, PhD North Shore University Hospital
National Institute of Environmental Health Sciences (NIEHS)
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP