Subcapsular Orchiectomy in Men With Klinefelter Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Odense University Hospital.
Recruitment status was  Recruiting
University of Copenhagen
Aarhus University Hospital
Information provided by (Responsible Party):
Jens Fedder, Odense University Hospital Identifier:
First received: December 8, 2012
Last updated: December 13, 2012
Last verified: December 2012
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:

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.


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

Inclusion Criteria:

  • Klinefelter
  • 15-40 years of age

Exclusion Criteria:

  • inability to understand the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01750632

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jens Fedder, Professor, Consultant, Ph.D., Odense University Hospital 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
Chromosome Disorders
Congenital Abnormalities
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Gonadal Disorders
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Urogenital Abnormalities processed this record on May 26, 2016