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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02006316
Other study ID # SeoulNUH
Secondary ID
Status Completed
Phase N/A
First received March 17, 2010
Last updated May 13, 2014
Start date January 2000
Est. completion date March 2010

Study information

Verified date May 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date March 2010
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 45 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
Microsurgical subinguinal varicocelectomy


Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sperm concentration, motility, and morphology To observe the change of sperm concentration, motility, and morphology pre and postoperatively in the patients of inclusion criteria at postoperative 4months No
Secondary whether semen analysis should be done in men with clinical varicocele regardless of the chief complaint 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 No
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Completed NCT01463787 - Comparison of Outcomes of Two Approaches in Microsurgical Varicocelectomy in Chinese Infertile Males: A Prospective Randomized, Controlled Trial Phase 4