Unraveling the Klinefelter's Disease Physiopathology (KLINEFELTER)

August 11, 2023 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Unraveling the Klinefelter's Disease Physiopathology by Organoid Model

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires St Luc
        • Contact:
          • Christine Wyns, MD,PhD
        • Principal Investigator:
          • Christine Wyns, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Klinefelter

Exclusion Criteria:

  • Mosaicism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infertile patients
Infertile patients going to surgery for fertility preservation or infertility treatment at University Clinic Saint-Luc Brussels
Procedure: Testicular biopsy
Testicular biopsy is a clinical procedure for extraction of testicular tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Klinefelter's infertility physiopathology
Time Frame: Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.
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.
Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Christine Wyns, MD, PhD, Cliniques Universitaires St Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2018

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/27AVR/196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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