- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02006316
Beneficial Effects of Microsurgical Varicocelectomy on Semen Parameters for Causes Other Than Infertility
May 13, 2014 updated by: Soo Woong Kim, MD, Seoul National University Hospital
Beneficial Effects of Microsurgical Varicocelectomy on Semen Parameters in Patients Who Underwent Surgery for Causes Other Than Infertility
The purpose of this study is to evaluate whether clinical varicoceles are associated with abnormal semen parameters and whether varicocelectomy could improve the semen parameter in patients unrelated with infertility.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
While most studies are continued to validate the observations of significant improvements in sperm density and motility after varicocele ligation in infertile patients, there have been few studies to investigate the effects of varicocelectomy on semen parameters in adult men unrelated with infertility.
The purpose of this study was to determine whether varicocelectomy could improve the semen parameter of these patients as well as whether clinical varicoceles are associated with abnormal semen parameters in patients unrelated with infertility.
Study Type
Observational
Enrollment (Actual)
121
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass
Description
Inclusion Criteria:
- men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass
Exclusion Criteria:
- adolescents
- men with proven fertility or azoospermia
- men with preoperative normal sperm analysis
- available data to compare between preoperative and postoperative semen analyses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
varicoceles
men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sperm concentration, motility, and morphology
Time Frame: at postoperative 4months
|
To observe the change of sperm concentration, motility, and morphology pre and postoperatively in the patients of inclusion criteria
|
at postoperative 4months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
whether semen analysis should be done in men with clinical varicocele regardless of the chief complaint
Time Frame: at postoperative 4months
|
this result would show the need of performing semen analysis even in the patients with clinical varicocels due to causes other than infertility
|
at postoperative 4months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Soo Woong Kim, M.D.,Ph.D., Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2000
Primary Completion (Actual)
April 1, 2008
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
March 17, 2010
First Submitted That Met QC Criteria
December 4, 2013
First Posted (Estimate)
December 10, 2013
Study Record Updates
Last Update Posted (Estimate)
May 14, 2014
Last Update Submitted That Met QC Criteria
May 13, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SeoulNUH
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.
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