Hazardous Waste / Toxic Chemicals |
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Clinical Trial: Role of the toxic metal cadmium in the mechanism producing infertility with a varicocele
This study is currently recruiting patients.
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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 | Treatment or Intervention |
|---|---|
| Varicocele Male Infertility Hypospermatogenesis Non-obstructive azoospermia | Procedure: Varicocele repair |
MedlinePlus related topics: Infertility; Male Genital Disorders; Reproductive Health; Vascular Diseases
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Increased Testicular Cd2+ & Infertility with Varicocele ( a varicose vein in the scrotum)
Expected Total Enrollment: 400
Study start: May 2000; Expected completion: April 2005
Eligibility
Ages Eligible for Study: 21 Years - 55 Years, Genders Eligible for Study: Male
Accepts Healthy Volunteers
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
Location and Contact Information
Colleen Millan, MA 516-562-4038 cmillan@nshs.edu
New Jersey
University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden, Camden, New Jersey, 08103, United States; Recruiting
Joel L Marmar, MD, Sub-Investigator
New York
North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Colleen Millan, MA 516-562-4038 cmillan@nshs.edu
Susan H Benoff, Ph.D., Principal Investigator
Susan H Benoff, PhD, Principal Investigator, 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. No abstract available.
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.
Record last reviewed: August 2002
Last Updated: October 13, 2004
Record first received: August 27, 2002
ClinicalTrials.gov Identifier: NCT00044369
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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