KLINEFELTER: Unraveling the Klinefelter's Disease Physiopathology

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05997706
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 81.6
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Klinefelter Syndrome; Infertility, Male	Procedure: Testicular biopsy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Unraveling the Klinefelter's Disease Physiopathology by Organoid Model
• Actual Study Start Date: Jun 12, 2018
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Klinefelter

Exclusion Criteria:

• Mosaicism

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques Universitaires St Luc	Brussels		Belgium	1200

Sponsors and Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• ClinicalTrials.gov Identifier: NCT05997706
• Other Study ID Numbers: 2018/27AVR/196
• First Posted: Aug 18, 2023
• Last Update Posted: Aug 18, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain: Klinefelter Syndrome; fertility preservation, male
• Additional relevant MeSH terms: Infertility; Klinefelter Syndrome; Infertility, Male

Study Results

No Results Posted as of Aug 18, 2023