Autologous testicular tissue transplantation of prepubertal frozen testicular tissue
Autologous testicular tissue transplantation of prepubertal frozen testicular tissue: Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells.
If no spermatozoa suitable for ICSI are detected in the ejaculate, the investigators will perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.
Study summary
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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
* 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
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
Primary outcome measure(s)
Restoration of spermatogenesis and fertility by performing an autologous testicular tissue transplantation. Primary endpoint is the presence of spermatozoa in the graft. — Graft-removal of intratesticular and intrascrotal grafts is planned 12 months after grafting. Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells.
If the patient has no spermatozoa suitable for ICSI in the ejaculate in adulthood, the investigators will perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.
Grafting will be performed intra-testicular and intrascrotal for each patient. Grafts will be removed 12 months after grafting.
Primary endpoint is the presence of spermatozoa in the grafted tissue. In the IVF laboratory mechanical mincing and enzymatic digestion will be performed on the tissue to find spermatozoa. If spermatozoa are present concentration and motility will be available.
Trial sites (1)
Facility
City
Region
Status
UZ Brussel Centre for Reproductive Medicine
Brussels
Belgium
Recruiting
More Universitair Ziekenhuis Brussel trials in Belgium
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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