Back to resultsSubcapsular Orchiectomy in Men With Klinefelter Syndrome
Primary Purpose
Klinefelter Syndrome
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Orchiectomy
Sponsored by
About this trial
This is an interventional treatment trial for Klinefelter Syndrome
Eligibility Criteria
Inclusion Criteria:
- Klinefelter
- 15-40 years of age
Exclusion Criteria:
- inability to understand the study
Sites / Locations
- Fertility Clinic, Odense University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Orchiectomy
Arm Description
The patients undergo subcapsular orchiectomy
Outcomes
Primary Outcome Measures
Presence of testicular sperm
Secondary Outcome Measures
Clinical pregnancy rate after ICSI with retrieved testicular sperm
Full Information
NCT ID
NCT01750632
First Posted
December 8, 2012
Last Updated
October 3, 2016
Sponsor
Odense University Hospital
Collaborators
University of Copenhagen, Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01750632
Brief Title
Subcapsular Orchiectomy in Men With Klinefelter Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Copenhagen, Aarhus University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Klinefelter Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orchiectomy
Arm Type
Experimental
Arm Description
The patients undergo subcapsular orchiectomy
Intervention Type
Procedure
Intervention Name(s)
Orchiectomy
Intervention Description
The patients undergo subcapsular orchiectomy with basic surgical instruments. The patients are given local analgesia and sometimes universal anesthesia.
Primary Outcome Measure Information:
Title
Presence of testicular sperm
Time Frame
Between 1 and 6 months
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Predictive value of FSH and other hormones for the presence of testicular sperm
Time Frame
Between 1 and 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Klinefelter
15-40 years of age
Exclusion Criteria:
inability to understand the study
Facility Information:
Facility Name
Fertility Clinic, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
26254174
Citation
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.
Results Reference
result
Learn more about this trial
Subcapsular Orchiectomy in Men With Klinefelter Syndrome
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