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Autologous Testicular Tissue Transplantation
RECRUITINGN/ASponsored by Universitair Ziekenhuis Brussel
Actively Recruiting
PhaseN/A
SponsorUniversitair Ziekenhuis Brussel
Started2024-11-22
Est. completion2030-07-29
Eligibility
Age18 Years – 50 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05414045
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 adulthood and presence of a childwish, the investigators intend to perform the first in men autologous testicular tissue transplantation to restore fertility.
Eligibility
Age: 18 Years – 50 YearsSex: MALEHealthy volunteers accepted
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
Conditions3
CancerHematologic DiseasesSickle Cell Thalassemia
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Actively Recruiting
PhaseN/A
SponsorUniversitair Ziekenhuis Brussel
Started2024-11-22
Est. completion2030-07-29
Eligibility
Age18 Years – 50 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05414045