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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044369
First Posted: August 28, 2002
Last Update Posted: September 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
  Purpose

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

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 400
Study Start Date: May 2000
Estimated Study Completion Date: April 2005
  Eligibility

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:
ClinicalTrials.gov Identifier: NCT00044369     History of Changes
Other Study ID Numbers: 10496-CP-001
First Submitted: August 27, 2002
First Posted: August 28, 2002
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