Subcapsular Orchiectomy in Men With Klinefelter Syndrome

October 3, 2016 updated by: Jens Fedder, Odense University Hospital
Men with Klinefelter syndrome undergo unilateral subcapsular ochiectomy, and the removed testicular tissue is examined for presence of sperm and cryopreserved in small pieces for fertility treatment and scientific purposes. Prior to operation blood samples are frozen in a biobank.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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
      • Odense, Denmark, 5000
        • Fertility Clinic, Odense University 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

13 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Klinefelter
  • 15-40 years of age

Exclusion Criteria:

  • inability to understand the study

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orchiectomy
The patients undergo subcapsular orchiectomy
Procedure: Orchiectomy
The patients undergo subcapsular orchiectomy with basic surgical instruments. The patients are given local analgesia and sometimes universal anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of testicular sperm
Time Frame: Between 1 and 6 months
Between 1 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate after ICSI with retrieved testicular sperm
Time Frame: participants will be followed for the duration of fertility treatment, an expected average of 6 months
participants will be followed for the duration of fertility treatment, an expected average of 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Predictive value of FSH and other hormones for the presence of testicular sperm
Time Frame: Between 1 and 6 months
Between 1 and 6 months

Collaborators and Investigators

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

Sponsor

Odense University Hospital

Collaborators

Aarhus University Hospital
University of Copenhagen

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

August 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 8, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lab.Reprod.Biol.-Horsens-02
  • M-20100041

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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