Status:
RECRUITING
Autologous Testicular Tissue Transplantation
Lead Sponsor:
Universitair Ziekenhuis Brussel
Collaborating Sponsors:
Vrije Universiteit Brussel
Conditions:
Cancer
Sickle Cell Thalassemia
Eligibility:
MALE
18-50 years
Phase:
NA
Brief Summary
Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells (SSCs) in case of imminent gonadotoxic treatment during childhood. In case of total azoospermia in a...
Detailed Description
Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells (SSCs). In 2002, the University hospital in Brussels (UZB) was the first hospital worldwide to offer...
Eligibility Criteria
Inclusion
- 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
- Desire to become a parent at the moment of intake
- Stable relationship with a female partner and minimal one year cohabiting
- Age of female partner \< 43 year
- Azoospermia 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 SSCs (positive MAGE staining) in one or two of the thawed fragments (If absence of SSCs 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
Exclusion
Key Trial Info
Start Date :
November 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2030
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05414045
Start Date
November 22 2024
End Date
October 29 2030
Last Update
April 3 2025
Active Locations (1)
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1
UZ Brussel Centre for Reproductive Medicine
Brussels, Belgium, 1090