Role of the Toxic Metal Cadmium in the Mechanism Producin... | NCT00044369

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

NCT00044369

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Status

Completed

Last Update Posted

Sep 4, 2006Estimated

Enrollment

400

Phase

Not provided

Conditions

Varicocele
Male Infertility
Hypospermatogenesis
Non-Obstructive Azoospermia

Interventions

Varicocele repair

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2000

Primary Completion Date

Not provided

Completion Date

Apr 2005

First Submitted Date

Aug 27, 2002

First Submission Date that Met QC Criteria

Aug 27, 2002

First Posted Date

Aug 28, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2006

Last Update Posted Date

Sep 4, 2006Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400

Name	Type	Description	Arm Group Labels	Other Names
Varicocele repair	Procedure

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan H Benoff, PhD	North Shore University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden		Camden	New Jersey	08103	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11212074	Background	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.
9022613	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.

ID	Term
D014646	Varicocele
D007248	Infertility, Male
D009845	Oligospermia

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases