Autologous Testicular Tissue Transplantation
- Conditions
- CancerSickle Cell ThalassemiaHematologic Diseases
- Registration Number
- NCT05414045
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
The eligible patients opted as a prepubertal boy to enroll in the fertility preservation<br>pro-gram and on the moment of cancer diagnosis or hematological disorder, their parents<br>have agreed to cryopreserve testicular tissue for later autologous transplantation.<br><br>Inclusion Criteria:<br><br> - At least 18 years old<br><br> - Desire to become a parent at the moment of intake<br><br> - Stable relationship with a female partner and minimal one year cohabiting<br><br> - Age of female partner < 43 year<br><br> - Azoospermia on 2 semen analyses<br><br> - Normal standardised preliminary and preoperative bloodsampling results<br><br> - Complete remission of the oncological or hematological disease<br><br> - Approval of the treating oncologist or other specialist in case of non-oncological<br> disease as reason for the testicular tissue preservation as a child<br><br> - Risk for presence of malignant cells in testicular tissue is negligible (according<br> to multidisciplinary assessment)<br><br> - Presence of SSCs (positive MAGE staining) in one or two of the thawed fragments (If<br> absence of SSCs in two of the thawed fragments, the case will be discussed<br> multidisciplinary)<br><br> - Written informed consent for the transplantation of cryopreserved testicular tissue<br> and follow-up after the procedure and of children born eventually after this<br> procedure<br><br>Exclusion criteria:<br><br> - Risk for presence of malignant cells in the testicular tissue<br><br> - Contra-indication for surgery<br><br> - Contra-indication for pregnancy in the female partner<br><br> - BMI > 32<br><br> - Heavy smoking (=10 cigarettes/day)<br><br> - Instable psychological condition
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Restoration of spermatogenesis and fertility by performing an autologous testicular tissue transplantation. Primary endpoint is the presence of spermatozoa in the graft.
- Secondary Outcome Measures
Name Time Method Histological study to define the optimal transplantation site;Imaging study;Endocrinological (hormonal) study;Biomarker Study;Complications