Subcapsular Orchiectomy in Men With Klinefelter Syndrome

NCT ID: NCT01750632

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Klinefelter Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Orchiectomy

The patients undergo subcapsular orchiectomy

Group Type EXPERIMENTAL

Orchiectomy

Intervention Type PROCEDURE

The patients undergo subcapsular orchiectomy with basic surgical instruments. The patients are given local analgesia and sometimes universal anesthesia.

Interventions

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Orchiectomy

The patients undergo subcapsular orchiectomy with basic surgical instruments. The patients are given local analgesia and sometimes universal anesthesia.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Klinefelter
* 15-40 years of age

Exclusion Criteria

* inability to understand the study
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jens Fedder

Professor, Consultant, Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fertility Clinic, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 26254174 (View on PubMed)

Other Identifiers

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M-20100041

Identifier Type: -

Identifier Source: secondary_id

Lab.Reprod.Biol.-Horsens-02

Identifier Type: -

Identifier Source: org_study_id

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