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CompletedNCT02006316Updated May 14, 2014

Beneficial Effects of Microsurgical Varicocelectomy on Semen Parameters for Causes Other Than Infertility

An observational study in Varicocele, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to male participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2014-05-14.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
121
Ages
20 Years to 45 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Varicocele
03

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No
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

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

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
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
121 participants (actual)

Groups and cohorts

  • varicoceles

    men with clinical varicoceles underwent microsurgical varicocelectomy due to causes other than infertility such as testicular pain, discomfort or scrotal mass

    Procedure: Microsurgical subinguinal varicocelectomy

Interventions

  • ProcedureMicrosurgical subinguinal varicocelectomy
05

What researchers measure

Primary outcomes

  1. Sperm concentration, motility, and morphology

    To observe the change of sperm concentration, motility, and morphology pre and postoperatively in the patients of inclusion criteria

    Time frame: at postoperative 4months

Secondary outcomes

  1. 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

    Time frame: at postoperative 4months

06

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
07

Registry details

Key details

Study ID
NCT02006316
Lead sponsor
Seoul National University Hospital
Responsible party
Soo Woong Kim, MD (Professor, Seoul National University Hospital) — Principal investigator
First posted
Dec 10, 2013
Start date
Jan 2000
Primary completion
Apr 2008
Completion
Mar 2010
Last update
May 14, 2014

Study contacts

Soo Woong Kim, M.D.,Ph.D.
study chair · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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