Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-01 @ 8:44 PM
Study NCT ID:
NCT00044369
Status:
COMPLETED
Last Update Posted:
2006-09-04
First Post:
2002-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014646', 'term': 'Varicocele'}, {'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D009845', 'term': 'Oligospermia'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2005-04'}, 'lastUpdateSubmitDate': '2006-09-01', 'studyFirstSubmitDate': '2002-08-27', 'studyFirstSubmitQcDate': '2002-08-27', 'lastUpdatePostDateStruct': {'date': '2006-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-08-28', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Varicocele', 'environmental toxins', 'male infertility', 'cadmium'], 'conditions': ['Varicocele', 'Male Infertility', 'Hypospermatogenesis', 'Non-Obstructive Azoospermia']}, 'referencesModule': {'references': [{'pmid': '11212074', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9022613', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11021525', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1046/j.1439-0272.2000.00401.x.'}, {'pmid': '10782569', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1093/humupd/6.2.107.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nBased 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).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Healthy male with varicocele (grades 2 \\[palpable\\] or 3 \\[visible, palpable\\]) and no other diagnosed cause for infertility\n* Non-smoker\n* Actively desiring children but never having initiated a pregnancy\n* Female partner having no unresolved fertility issues'}, 'identificationModule': {'nctId': 'NCT00044369', 'briefTitle': 'Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Environmental Health Sciences (NIEHS)'}, 'officialTitle': 'Increased Testicular Cd2+ & Infertility With Varicocele ( a Varicose Vein in the Scrotum)', 'orgStudyIdInfo': {'id': '10496-CP-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Varicocele repair', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Susan H Benoff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Shore University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Environmental Health Sciences (NIEHS)', 'class': 'NIH'}}}}