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

Completed

• Conditions: Varicocele; Male Infertility; Hypospermatogenesis; Non-Obstructive Azoospermia

• Registration Number: NCT00044369
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2002-08-27
• Study First Submitted QC: 2002-08-27
• Study First Posted: 2002-08-28
• Study Completion: 2005-04
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-01
• Last Update Posted: 2006-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden; 🇺🇸 Camden, New Jersey, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States