NCT05414045 Autologous Testicular Tissue Transplantation
| NCT ID | NCT05414045 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2024-11-22 |
| Primary Completion | 2030-07-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2024-11-22 with a primary completion date of 2030-07-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells in case of imminent gonadotoxic treatment during childhood. In case of total azoospermia or absence of spermatozoa that can be used for intra-cytoplasmic injection (ICSI) in adulthood, the investigators intend to perform the first in men autologous testicular tissue transplantation to restore fertility.
Eligibility Criteria
The eligible patients opted as a prepubertal boy to enroll in the fertility preservation program and on the moment of cancer diagnosis or hematological disorder, their parents have agreed to cryopreserve testicular tissue for later autologous transplantation. Inclusion Criteria: * At least 18 years old * In case of female partner, age \< 43 year * Absence of spermatozoa that can be used for ICSI on 2 semen analyses * Normal standardised preliminary and preoperative bloodsampling results * Complete remission of the oncological or hematological disease * Approval of the treating oncologist or other specialist in case of non-oncological disease as reason for the testicular tissue preservation as a child * Risk for presence of malignant cells in testicular tissue is negligible (according to multidisciplinary assessment) * Presence of spermatogonial stem cells (positive MAGE staining) in one or two of the thawed fragments (If absence of spermatogonial stem cells in two of the thawed fragments, the case will be discussed multidisciplinary) * Written informed consent for the transplantation of cryopreserved testicular tissue and follow-up after the procedure and of children born eventually after this procedure Exclusion criteria: * Risk for presence of malignant cells in the testicular tissue * Contra-indication for surgery * Contra-indication for pregnancy in the female partner * BMI \> 32 * Heavy smoking (≥10 cigarettes/day) * Instable psychological condition
Contact & Investigator
Veerle Vloeberghs, MD
PRINCIPAL INVESTIGATOR
CRG UZ Brussel
Frequently Asked Questions
Who can join the NCT05414045 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 50 Years, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05414045 currently recruiting?
Yes, NCT05414045 is actively recruiting participants. Contact the research team at veerle.vloeberghs@uzbrussel.be for enrollment information.
Where is the NCT05414045 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT05414045 clinical trial?
NCT05414045 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Veerle Vloeberghs, MD at CRG UZ Brussel. The trial plans to enroll 5 participants.
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