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Autologous Testicular Tissue Transplantation

Autologous Testicular Tissue Transplantation

Recruiting
18-50 years
Male
Phase N/A

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Overview

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.

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 testicular tissue cryobanking for fertility preservation in boys and ado-lescents. Since then, several other centers in Europe and USA have implemented similar fertility preservation programs. However, up till now, autologous transplantations of cryopreserved testicular tissue have not been performed yet.

As soon as a patient returns to the Centre for Reproductive Medicine at UZB with the request to transplant the preserved testicular tissue, the investigators will first analyse semen and blood. If spermatozoa are found in their semen, men can immediately enroll in standard care for natural conception, intra-uterine insemination (IUI), in-vitro fertilization (IVF) or intra-cytoplasmic injection (ICSI). However, in case no spermatozoa are found in the ejaculate or after performing a testicular biopsy (TESE), the investigators intend to propose and eventually perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.

Eligibility

The eligible patients opted as a prepubertal boy to enroll in the fertility preservation

        pro-gram 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

Study details
    Cancer
    Sickle Cell Thalassemia
    Hematologic Diseases

NCT05414045

Universitair Ziekenhuis Brussel

26 January 2024

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