Autologous Testicular Tissue Transplantation
Recruiting now · Not applicable
Conditions studied: Cancer, Sickle Cell Thalassemia, Hematologic Diseases
In brief
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.
Key facts
- Study ID
- NCT05414045
- Run by
- Universitair Ziekenhuis Brussel
- People needed
- 5
- Starts
- 2024-11-22
- Expected to finish
- 2030-10-29
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older, up to 50. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UZ Brussel Centre for Reproductive Medicine — Brussels, Belgium (enrolling)
Full record on ClinicalTrials.gov
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