Unraveling the Klinefelter's Disease Physiopathology

NCT ID: NCT05997706

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-12

Study Completion Date

2025-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Klinefelter Syndrome Infertility, Male

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Infertile patients

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

Group Type EXPERIMENTAL

Testicular biopsy

Intervention Type PROCEDURE

Testicular biopsy is a clinical procedure for extraction of testicular tissue

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Testicular biopsy

Testicular biopsy is a clinical procedure for extraction of testicular tissue

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Klinefelter

Exclusion Criteria

* Mosaicism
Minimum Eligible Age

5 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christine Wyns, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques Universitaires St Luc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cliniques Universitaires St Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christine Wyns, MD, PhD

Role: CONTACT

+3227649501

Maria Grazia Giudice, MD

Role: CONTACT

+32485256903

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christine Wyns, MD,PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Giudice MG, Kanbar M, Poels J, Duquenne A, Wyns C. Long-term culture of human Sertoli cells from adult Klinefelter patients as a first step to develop new tools for unravelling the testicular physiopathology. Hum Reprod. 2024 Nov 1;39(11):2400-2410. doi: 10.1093/humrep/deae201.

Reference Type DERIVED
PMID: 39237101 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018/27AVR/196

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sex Selection of Human Spermatozoa
NCT05500573 RECRUITING NA
Contraception in Normal and Subnormal Men
NCT00167141 TERMINATED PHASE2