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

• Sponsor: National Institute of Environmental Health Sciences (NIEHS) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00044369
• Collaborator: (none)
• Enrollment: 400
• Locations: 2
• Duration (Months): 59
• Patients Per Site: 200
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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	Phase
Varicocele; Male Infertility; Hypospermatogenesis; Non-Obstructive Azoospermia	Procedure: Varicocele repair

Study Design

• Study Type: Observational
• Observational Model: Defined Population
• Time Perspective: Prospective
• Official Title: Increased Testicular Cd2+ & Infertility With Varicocele ( a Varicose Vein in the Scrotum)
• Study Start Date: May 1, 2000
• Study Completion Date: Apr 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden	Camden	New Jersey	United States	08103
2	North Shore University Hospital	Manhasset	New York	United States	11030

Sponsors and Collaborators

• National Institute of Environmental Health Sciences (NIEHS)

Investigators

• Principal Investigator: Susan H Benoff, PhD, North Shore University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• ClinicalTrials.gov Identifier: NCT00044369
• Other Study ID Numbers: 10496-CP-001
• First Posted: Aug 28, 2002
• Last Update Posted: Sep 4, 2006
• Last Verified: Sep 1, 2006

• Keywords provided by , ,: Varicocele; environmental toxins; male infertility; cadmium
• Additional relevant MeSH terms: Infertility; Infertility, Male; Azoospermia; Varicocele; Oligospermia

Study Results

No Results Posted as of Sep 4, 2006