Unraveling the Klinefelter's Disease Physiopathology

Infertility, Male Clinical Trial

— KLINEFELTER  

Official title:

Unraveling the Klinefelter's Disease Physiopathology by Organoid Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997706
• Other study ID #: 2018/27AVR/196
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2018
• Est. completion date: April 1, 2025

Study information

• Verified date: August 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Christine Wyns, MD, PhD
• Phone: +3227649501
• Email: christine.wyns[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years to 50 Years

Eligibility

Inclusion Criteria:

• Klinefelter

Exclusion Criteria:

• Mosaicism

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Klinefelter Syndrome

Intervention

Procedure:
• Testicular biopsy
Testicular biopsy is a clinical procedure for extraction of testicular tissue

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.