VaricoceleNCT00044369
Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele
An observational study of Varicocele and Male Infertility, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Varicocele, Male Infertility, Hypospermatogenesis
- What is being tested?
- Varicocele repair
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2000to Apr 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden
Camden, New Jersey, 08103
North Shore University Hospital
Manhasset, New York, 11030
About this study
Official title: 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).
- Being tested
- Varicocele repair
- Keywords
- Varicocele, environmental toxins, male infertility, cadmium
- Medical subject headings
- Varicocele, Infertility, Male, Oligospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicocele repairProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2002 (estimated)
- Study startMay 2000
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan H Benoff, PhD, Principal investigator, North Shore University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044369
- Sponsor's protocol ID
- 10496-CP-001
- Status last verified
- Sep 2006
- First submitted
- 27 Aug 2002
- Last updated
- 4 Sep 2006
- Results posted
- No
Publications
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.
PubMed 11212074Benoff 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.
PubMed 9022613Benoff 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.
PubMed 11021525Benoff 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.
PubMed 10782569
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Testicular Cd2+ & Infertility With Varicocele ( a Varicose Vein in the Scrotum)
- ClinicalTrials.gov ID
- NCT00044369
- Acronym / sponsor ID
- 10496-CP-001
- Keywords
- Varicocele, environmental toxins, male infertility, cadmium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- May 2000
- Study completion
- Apr 2005
- First posted
- 28 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varicocele repair | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2006.
- Background: PubMed 11212074Benoff 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.
- Background: PubMed 9022613Benoff 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.
- Background: PubMed 11021525Benoff 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.
- Background: PubMed 10782569Benoff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan H Benoff, PhD principal investigator
North Shore University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicocele and Male Infertility, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00044369, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2006.