- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00044369
Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele
Increased Testicular Cd2+ & Infertility With Varicocele ( a Varicose Vein in the Scrotum)
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).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment
Contacts and Locations
Study Locations
-
-
New Jersey
-
Camden, New Jersey, United States, 08103
- University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden
-
-
New York
-
Manhasset, New York, United States, 11030
- North Shore University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Susan H Benoff, PhD, North Shore University Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10496-CP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Male Infertility
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMale Infertility, AzoospermiaUnited States
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Jinling Hospital, ChinaRecruitingMale Infertility Due to HypospermatogenesisChina
-
Reproductive Medicine Associates of New JerseyTerminated
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
Hillel Yaffe Medical CenterUnknownMale Infertility With Severe Oligo-terato-asteno-spermiaIsrael
-
Universitair Ziekenhuis BrusselRecruitingMale InfertilityBelgium
-
Istituto Clinico HumanitasRecruiting
Clinical Trials on Varicocele repair
-
Shaare Zedek Medical CenterUnknownIn Vitro Fertilization | Infertility, Male | Varicocele
-
Al-Yasmeen Fertility and Gynecology CenterBanon IVF Center Assiut, Egypt; Elite Fertility and Gynecology Center, Cairo... and other collaboratorsNot yet recruitingInfertility, Male
-
Adrien SchwitzguebelRecruitingAnterior Cruciate Ligament Rupture | SurgerySwitzerland
-
Makerere UniversityMulago Hospital, UgandaUnknown
-
University of Sao PauloUniversity of Sao Paulo General Hospital; Federal University of São Paulo; Irmandade... and other collaboratorsUnknown
-
University of AlexandriaCompletedPostoperative Complications | Bilateral Inguinal Hernia
-
Hôpital Universitaire Taher SfarUnknownVentral Hernia | Umbilical Hernia | Ventral Incisional HerniaTunisia
-
Hospital Clinic of BarcelonaRecruiting
-
Boston Medical CenterTerminatedPopliteal Artery AneurysmUnited States