Subcapsular Orchiectomy in Men With Klinefelter Syndrome

Klinefelter Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750632
• Other study ID #: Lab.Reprod.Biol.-Horsens-02
• Secondary ID: M-20100041
• Status: Completed
• Phase: N/A
• First received: December 8, 2012
• Last updated: October 3, 2016
• Start date: August 2010
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

• Klinefelter

• 15-40 years of age

Exclusion Criteria:

• inability to understand the study

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Klinefelter Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Denmark	Fertility Clinic, Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Aarhus University Hospital, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Predictive value of FSH and other hormones for the presence of testicular sperm		Between 1 and 6 months	No
Primary	Presence of testicular sperm		Between 1 and 6 months	No
Secondary	Clinical pregnancy rate after ICSI with retrieved testicular sperm		participants will be followed for the duration of fertility treatment, an expected average of 6 months	Yes