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

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ClinicalTrials.gov Identifier: NCT00044369

Recruitment Status : Completed

First Posted : August 28, 2002

Last Update Posted : September 4, 2006

Sponsor:

Information provided by:

National Institute of Environmental Health Sciences (NIEHS)

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

Study Design


Study Type :	Observational
Enrollment :	400 participants
Observational Model:	Defined Population
Primary Purpose:	Screening
Time Perspective:	Longitudinal
Time Perspective:	Prospective
Official Title:	Increased Testicular Cd2+ & Infertility With Varicocele ( a Varicose Vein in the Scrotum)
Study Start Date :	May 2000
Study Completion Date :	April 2005

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: CATSPER1-related nonsyndromic male infertility Y chromosome infertility Sensorineural deafness and male infertility

MedlinePlus related topics: Infertility Varicose Veins

Drug Information available for: Cadmium

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years to 55 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044369

Locations


United States, New Jersey
University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden
Camden, New Jersey, United States, 08103
United States, New York
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

More Information

Publications:

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, 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, 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 History of Changes
Other Study ID Numbers:	10496-CP-001
First Posted:	August 28, 2002 Key Record Dates
Last Update Posted:	September 4, 2006
Last Verified:	September 2006

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):


Varicocele environmental toxins male infertility cadmium

Additional relevant MeSH terms:


Infertility Infertility, Male Azoospermia Varicocele Oligospermia	Genital Diseases, Male Genital Diseases, Female Vascular Diseases Cardiovascular Diseases

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