Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?

May 23, 2013 updated by: Copenhagen University Hospital at Herlev
The purpose of this study is to determine if the pre-operative levels of sex-hormones can be used to identify the varicocele patients who can expect improvements in their semen parameters following varicocelectomy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

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

  • Denmark
      • Copenhagen, Denmark, 2100
        • University Department of Growth and Reproduction GR, Section 5064, Rigshospitalet
      • Herlev, Denmark, 2730
        • Department of Urology, Herlev Hospital

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:

  • Varicocele (grade 1-3) and surgery planned for this condition
  • At least 18 years of age

Exclusion Criteria:

  • Fever within 3 months before the first semen sample
  • Malformations of the uro-genital tract
  • Karyotype other than 46, XY or Y micro deletions
  • Endocrine disease
  • Chronic disease
  • Medications which reduce semen quality
  • Epididymitis within 6 months before surgery

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: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hormone/semen measurements before and after varicocelectomy
We will measure sex-hormone and semen quality in patients both before and after varicocelectomy. The purpose is to asses if preoperative hormone levels are predictive for who will have improved semen quality after surgery.
Procedure: Hormone and semen measurements before varicocelectomy
Before surgery we will measure sex-hormone levels and semen parameters. This will be repeated after the varicocelectomy to record any changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in semen parameters
Time Frame: February 2017 (anticipated duration of the study)
February 2017 (anticipated duration of the study)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in hormone levels
Time Frame: February 2017 (anticipated end of the study)
February 2017 (anticipated end of the study)

Collaborators and Investigators

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

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

Rigshospitalet, Denmark

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

February 1, 2011

Primary Completion (ANTICIPATED)

February 1, 2017

Study Completion (ANTICIPATED)

February 1, 2017

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (ESTIMATE)

February 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2010-067

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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