NCT02006316

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2010

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

8.3 years

First QC Date

March 17, 2010

Last Update Submit

May 13, 2014

Conditions

Varicocele

Outcome Measures

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

    at postoperative 4months

Secondary Outcomes (1)

  • whether semen analysis should be done in men with clinical varicocele regardless of the chief complaint

    at postoperative 4months

Study Arms (1)

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

Microsurgical subinguinal varicocelectomyPROCEDURE
varicoceles

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • adolescents
  • men with proven fertility or azoospermia
  • men with preoperative normal sperm analysis
  • available data to compare between preoperative and postoperative semen analyses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Soo Woong Kim, M.D.,Ph.D.

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2010

First Posted

December 10, 2013

Study Start

January 1, 2000

Primary Completion

April 1, 2008

Study Completion

March 1, 2010

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

KR(1)