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

NCT00044369 | Completed

• 1 other identifier: 10496-CP-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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).

Conditions

Varicocele; Male Infertility; Hypospermatogenesis; Non-Obstructive Azoospermia

Keywords

Varicocele; environmental toxins; male infertility; cadmium

Interventions

Varicocele repair PROCEDURE

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (2)

University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden

Camden, New Jersey, 08103, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Related Publications (4)

• Benoff S, Gilbert BR. Varicocele and male infertility: part I. Preface. Hum Reprod Update. 2001 Jan-Feb;7(1):47-54. doi: 10.1093/humupd/7.1.47. No abstract available.

  PMID: 11212074 BACKGROUND

• 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. doi: 10.1016/S0015-0282(97)81921-8.

  PMID: 9022613 BACKGROUND

• 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. doi: 10.1046/j.1439-0272.2000.00401.x.

  PMID: 11021525 BACKGROUND

• 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. doi: 10.1093/humupd/6.2.107.

  PMID: 10782569 BACKGROUND

MeSH Terms

Conditions

Varicocele; Infertility, Male; Oligospermia

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Infertility

Study Officials

• Susan H Benoff, PhD

  North Shore University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 27, 2002
• First Posted: August 28, 2002
• Study Start: May 1, 2000
• Study Completion: April 1, 2005
• Last Updated: September 4, 2006

Record last verified: 2006-09

Locations

US (2)