Trial record 15 of 762 for:    "Infertility"

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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00044369
First received: August 27, 2002
Last updated: September 1, 2006
Last verified: September 2006
  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
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

Ages Eligible for Study:   21 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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
Study First Received: August 27, 2002
Last Updated: September 1, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Varicocele
environmental toxins
male infertility
cadmium

Additional relevant MeSH terms:
Azoospermia
Infertility
Infertility, Male
Oligospermia
Varicocele
Genital Diseases, Male
Genital Diseases, Female
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014