We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Subcapsular Orchiectomy in Men With Klinefelter Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01750632
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : October 4, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Klinefelter Syndrome Procedure: Orchiectomy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2010
Primary Completion Date : February 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01750632     History of Changes
Other Study ID Numbers: Lab.Reprod.Biol.-Horsens-02
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 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