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Subcapsular Orchiectomy in Men With Klinefelter Syndrome

This study has been completed.
University of Copenhagen
Aarhus University Hospital
Information provided by (Responsible Party):
Jens Fedder, Odense University Hospital Identifier:
First received: December 8, 2012
Last updated: October 3, 2016
Last verified: October 2016
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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Jens Fedder, Odense University Hospital:

Primary Outcome Measures:
  • Presence of testicular sperm [ Time Frame: Between 1 and 6 months ]

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 ]

Other Outcome Measures:
  • Predictive value of FSH and other hormones for the presence of testicular sperm [ Time Frame: Between 1 and 6 months ]

Enrollment: 14
Study Start Date: August 2010
Study Completion Date: December 2014
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 anesthesia.


Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes 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
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Please refer to this study by its identifier: NCT01750632

Fertility Clinic, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Copenhagen
Aarhus University Hospital
  More Information

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
Study First Received: December 8, 2012
Last Updated: October 3, 2016

Additional relevant MeSH terms:
Klinefelter Syndrome
Pathologic Processes
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 processed this record on May 25, 2017