The Role of Microsurgery in Surgical Treatment of Varicocele.

March 4, 2019 updated by: Medical University of Warsaw
This study is to set the place of microsurgery in surgical treatment od varicocele in infertile male. Fourty patients will undergo microsurgical subinguinal varicocelectomy while the control group consisting of 20 patients wil undergo laparoscopic varicocelectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

  • Poland
      • Warsaw, Poland, 02-005
        • Recruiting
        • Chair and Department of Urology Warsaw Medical University.
        • Contact:

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • clinical varicocele
  • infertility duration of min one year
  • poor semen quality
  • otherwise unexplained infertility in the couple

Exclusion Criteria:

  • female infertility

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: microsurgery
40 patients will undergo subinguinal microscopic varicocelectomy
Procedure: subinguinal microscopic varicocelectomy
ACTIVE_COMPARATOR: laparoscopy
20 patients will undergo laparoscopic varicocelectomy
Procedure: laparoscopic varicocelectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate after the intervention
Time Frame: one yaer after the intervention
one yaer after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2015

Primary Completion (ANTICIPATED)

July 1, 2019

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (ESTIMATE)

March 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • microvl/2015

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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