Unraveling the Klinefelter's Disease Physiopathology

Not Applicable

Recruiting

• Conditions: Infertility, Male; Klinefelter Syndrome
• Interventions: Procedure: Testicular biopsy

• Registration Number: NCT05997706
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study Start: 2018-06-12
• Study First Submitted: 2019-06-27
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-11
• Last Update Submitted: 2023-08-11
• Study First Posted: 2023-08-18
• Last Update Posted: 2023-08-18
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Klinefelter

Exclusion Criteria

• Mosaicism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infertile patients	Testicular biopsy	Infertile patients going to surgery for fertility preservation or infertility treatment at University Clinic Saint-Luc Brussels

Primary Outcome Measures

Name	Time	Method
Klinefelter's infertility physiopathology	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.

Trial Locations

Locations (1)

Cliniques Universitaires St Luc; 🇧🇪 Brussels, Belgium