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

Male Infertility Clinical Trial

Official title:

Increased Testicular Cd2+ & Infertility With Varicocele ( a Varicose Vein in the Scrotum)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044369
• Other study ID #: 10496-CP-001
• Status: Completed
• Phase: N/A
• First received: August 27, 2002
• Last updated: September 1, 2006
• Start date: May 2000
• Est. completion date: April 2005

Study information

• Verified date: September 2006
• Source: National Institute of Environmental Health Sciences (NIEHS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 55 Years

Eligibility

• 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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Azoospermia
• Hypospermatogenesis
• Infertility
• Infertility, Male
• Male Infertility
• Non-Obstructive Azoospermia
• Oligospermia
• Varicocele

Intervention

Procedure:
• Varicocele repair

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Benoff S, Cooper GW, Centola GM, Jacob A, Hershlag A, Hurley IR. Metal ions and human sperm mannose receptors. Andrologia. 2000 Sep;32(4-5):317-29. — View Citation

Benoff S, Gilbert BR. Varicocele and male infertility: part I. Preface. Hum Reprod Update. 2001 Jan-Feb;7(1):47-54. Review. — View Citation

Benoff S, Hurley IR, Barcia M, Mandel FS, Cooper GW, Hershlag A. A potential role for cadmium in the etiology of varicocele-associated infertility. Fertil Steril. 1997 Feb;67(2):336-47. — View Citation

Benoff S, Jacob A, Hurley IR. Male infertility and environmental exposure to lead and cadmium. Hum Reprod Update. 2000 Mar-Apr;6(2):107-21. Review. — View Citation