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Subcapsular Orchiectomy in Men With Klinefelter Syndrome

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ClinicalTrials.gov Identifier: NCT01750632
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : October 4, 2016
Sponsor:
Collaborators:
University of Copenhagen
Aarhus University Hospital
Information provided by (Responsible Party):
Jens Fedder, Odense University Hospital

Study Description
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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 Phase
Klinefelter Syndrome Procedure: Orchiectomy Not Applicable

Study Design
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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
Actual Primary Completion Date : February 2014
Actual Study Completion Date : December 2014

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Arms and Interventions
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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
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Denmark
Fertility Clinic, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Copenhagen
Aarhus University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Syndrome
Klinefelter Syndrome
Disease
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