NCT01750632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

3.5 years

First QC Date

December 8, 2012

Last Update Submit

October 3, 2016

Conditions

Klinefelter Syndrome

Outcome Measures

Primary Outcomes (1)

  • Presence of testicular sperm

    Between 1 and 6 months

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • Predictive value of FSH and other hormones for the presence of testicular sperm

    Between 1 and 6 months

Study Arms (1)

Orchiectomy

EXPERIMENTAL

The patients undergo subcapsular orchiectomy

Procedure: Orchiectomy

Interventions

OrchiectomyPROCEDURE

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

Orchiectomy

Eligibility Criteria

Age15 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Klinefelter
  • years of age

You may not qualify if:

  • inability to understand the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic, Odense University Hospital

Odense, 5000, Denmark

Location

Related 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.2015.06.044. Epub 2015 Aug 4.

    PMID: 26254174RESULT

MeSH Terms

Conditions

Klinefelter Syndrome

Interventions

Orchiectomy

Condition Hierarchy (Ancestors)

Sex Chromosome Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornGonadal DisordersEndocrine System DiseasesHypogonadism

Intervention Hierarchy (Ancestors)

CastrationEndocrine Surgical ProceduresSurgical Procedures, OperativeUrogenital Surgical ProceduresUrologic Surgical Procedures, MaleUrologic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Consultant, Ph.D.

Study Record Dates

First Submitted

December 8, 2012

First Posted

December 17, 2012

Study Start

August 1, 2010

Primary Completion

February 1, 2014

Study Completion

December 1, 2014

Last Updated

October 4, 2016

Record last verified: 2016-10

Locations

DK(1)