Klinefelter SyndromeKLINEFELTERNCT05997706
Unraveling the Klinefelter's Disease Physiopathology
A study testing Testicular biopsy in people with Klinefelter Syndrome and Infertility, Male, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 5 to 50 years, men only
- Conditions the study is for
- Klinefelter Syndrome, Infertility, Male
- What is being tested?
- Testicular biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Jun 2018to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 50 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Klinefelter
Who cannot join
- Mosaicism
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires St Luc
Brussels, 1200
Christine Wyns, MD,PhD
Christine Wyns, MD,PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Klinefelter Syndrome, Infertility, Male
- Being tested
- Testicular biopsy
- Keywords
- Klinefelter Syndrome, fertility preservation, male
- Medical subject headings
- Klinefelter Syndrome, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testicular biopsyProcedure or surgery
Testicular biopsy is a clinical procedure for extraction of testicular tissue
| Study group | Role | What they receive |
|---|---|---|
| Infertile patients | Experimental | Infertile patients going to surgery for fertility preservation or infertility treatment at University Clinic Saint-Luc Brussels Receives: Procedure: Testicular biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start12 Jun 2018
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Klinefelter SyndromeStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Wyns, MD, PhD, Principal investigator, Cliniques Universitaires St Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997706
- Sponsor's protocol ID
- 2018/27AVR/196
- Acronym
- KLINEFELTER
- Status last verified
- Aug 2023
- First submitted
- 27 Jun 2019
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39237101
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling the Klinefelter's Disease Physiopathology by Organoid Model
- ClinicalTrials.gov ID
- NCT05997706
- Acronym / sponsor ID
- KLINEFELTER / 2018/27AVR/196
- Conditions
- Klinefelter Syndrome, Infertility, Male
- Keywords
- Klinefelter Syndrome, fertility preservation, male
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile patients | Experimental | Procedure: Testicular biopsyInfertile patients going to surgery for fertility preservation or infertility treatment at University Clinic Saint-Luc Brussels |
Who may qualify
- Ages
- 5 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Klinefelter
Key exclusion criteria (1 listed)
- Mosaicism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testicular biopsyTesticular biopsy is a clinical procedure for extraction of testicular tissue | Procedure or surgery | Infertile patients |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Derived from this study: PubMed 39237101Giudice 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Wyns, MD, PhD principal investigator
Cliniques Universitaires St Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testicular biopsy in people with Klinefelter Syndrome and Infertility, Male, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Wyns, MD, PhD (+3227649501, christine.wyns@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Klinefelter's infertility physiopathology (time frame: Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05997706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.