Back to results

Unraveling the Klinefelter's Disease Physiopathology (KLINEFELTER)

Primary Purpose

Klinefelter Syndrome, Infertility, Male

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Testicular biopsy

About this trial

This is an interventional basic science trial for Klinefelter Syndrome focused on measuring Klinefelter Syndrome, fertility preservation, male

Eligibility Criteria

5 Years - 50 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Klinefelter Exclusion Criteria: Mosaicism

Sites / Locations

Cliniques Universitaires St LucRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infertile patients

Arm Description

Infertile patients going to surgery for fertility preservation or infertility treatment at University Clinic Saint-Luc Brussels

Outcomes

Primary Outcome Measures

Klinefelter's infertility physiopathology

Testicular biopsies will be digested using two steps enzymatic protocol. Cell suspensions will be in vitro cultured during 2 months. The following analyses will be performed: cells counts, cells characterisation by immunofluorescence and RTqPCR specific for the cell type, cells karyotypes.

Secondary Outcome Measures

Full Information

NCT ID

NCT05997706

First Posted

June 27, 2019

Last Updated

August 11, 2023

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT05997706

Brief Title

Unraveling the Klinefelter's Disease Physiopathology

Acronym

KLINEFELTER

Official Title

Unraveling the Klinefelter's Disease Physiopathology by Organoid Model

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 12, 2018 (Actual)

Primary Completion Date

April 1, 2025 (Anticipated)

Study Completion Date

April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Organoid Model to unravel Klinefelter Syndrome infertility Klinefelter Syndrome (KS) is characterized by the presence of an extra chromosome X in male (47,XXY), it is the most frequent genetic cause of azoospermia in adult men. The investigators will isolate and expand spermatogonial cells from KS patients, then using an organoid model investigators will compare the behavior of these Spermatogonia from KS patients when interacting with four combinations of somatic cell types incorporated in the Extra Cellular Matrix hydrogel.

Detailed Description

Men with Klinefelter Syndrome candidate for TESE or microTESE (testicular sperm extraction) for azoospermia. One extra testicular biopsy (1-2 mm) will be cryopreserved and used later for the cells isolation and culture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Klinefelter Syndrome, Infertility, Male

Keywords

Klinefelter Syndrome, fertility preservation, male

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Infertile patients

Arm Type

Experimental

Arm Description

Infertile patients going to surgery for fertility preservation or infertility treatment at University Clinic Saint-Luc Brussels

Intervention Type

Procedure

Intervention Name(s)

Testicular biopsy

Intervention Description

Testicular biopsy is a clinical procedure for extraction of testicular tissue

Primary Outcome Measure Information:

Title

Klinefelter's infertility physiopathology

Description

Time Frame

Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Klinefelter Exclusion Criteria: Mosaicism

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christine Wyns, MD, PhD

Phone

+3227649501

christine.wyns@uclouvain.be

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Grazia Giudice, MD

Phone

+32485256903

maria.giudice@uclouvain.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christine Wyns, MD, PhD

Organizational Affiliation

Cliniques Universitaires St Luc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques Universitaires St Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christine Wyns, MD,PhD

First Name & Middle Initial & Last Name & Degree

Christine Wyns, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Unraveling the Klinefelter's Disease Physiopathology

We'll reach out to this number within 24 hrs