Autologous Testicular Tissue Transplantation

Universitair Ziekenhuis Brussel

Status

Enrolling

Conditions

Sickle Cell Thalassemia

Cancer

Hematologic Diseases

Treatments

Procedure: Autologous testicular tissue transplantation of prepubertal frozen testicular tissue

Study type

Interventional

Funder types

Other

Identifiers

NCT05414045

2019-477

Details and patient eligibility

About

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.

Full 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 the investigators intend to propose and eventually perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.

Enrollment

5 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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