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Subcapsular Orchiectomy in Men With Klinefelter Syndrome

This study is currently recruiting participants.
Verified December 2012 by Odense University Hospital
Sponsor:
Collaborators:
University of Copenhagen
Aarhus University Hospital
Information provided by (Responsible Party):
Jens Fedder, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01750632
First received: December 8, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Klinefelter Syndrome
 Procedure: Orchiectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Presence of testicular sperm [ Time Frame: Between 1 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Predictive value of FSH and other hormones for the presence of testicular sperm [ Time Frame: Between 1 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 anaestesia.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Klinefelter
  • 15-40 years of age

Exclusion Criteria:

  • inability to understand the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750632

Locations
Denmark
Fertility Clinic, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Jens Fedder, Professor     +45 268 20 368     fedder@dadlnet.dk    
Principal Investigator: Jens Fedder, Professor            
Sponsors and Collaborators
Odense University Hospital
University of Copenhagen
Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Jens Fedder, Professor, Consultant, Ph.D., Odense University Hospital
ClinicalTrials.gov Identifier: NCT01750632     History of Changes
Other Study ID Numbers: Lab.Reprod.Biol.-Horsens-02, M-20100041
Study First Received: December 8, 2012
Last Updated: December 13, 2012
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Klinefelter Syndrome
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
 Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism

ClinicalTrials.gov processed this record on June 13, 2013