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

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:

Genetics Home Reference related topics: Klinefelter syndrome persistent Müllerian duct syndrome

MedlinePlus related topics: Klinefelter's Syndrome

Genetic and Rare Diseases Information Center resources: Klinefelter Syndrome

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 (Child, Adult)
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

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 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fedder J, Gravholt CH, Kristensen SG, Marcussen N, Engvad B, Milton AM, Andersen CY. Testicular Sperm Sampling by Subcapsular Orchiectomy in Klinefelter Patients: A New Simplified Treatment Approach. Urology. 2015 Oct;86(4):744-50. doi: 10.1016/j.urology.2015.06.044. Epub 2015 Aug 4.


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:


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

ClinicalTrials.gov processed this record on September 23, 2016

To Top