Autologous Testicular Tissue Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous testicular tissue transplantation of prepubertal frozen testicular tissue.
- Who it may be relevant to
- Registry conditions: Cancer, Sickle Cell Thalassemia, Hematologic Diseases. Basic parameters: 18 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Autologous Testicular Tissue Transplantation for Fertility Restoration
Overview
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.
Detailed description
Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells. 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, if no spermatozoa suitable for ICSI are detected 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.
Interventions
- Procedure 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.
Primary outcome measures
- Restoration of spermatogenesis and fertility by performing an autologous testicular tissue transplantation. Primary endpoint is the presence of spermatozoa in the graft. [Time frame: Graft-removal of intratesticular and intrascrotal grafts is planned 12 months after grafting.]
Secondary outcome measures (5)
- Histological study to define the optimal transplantation site [Time frame: Graft-removal of intratesticular grafts and intrascrotal grafts are planned 12 months after initial grafting. Histological study will be performed 12 months after initial grafting]
- Imaging study [Time frame: Each patient in the study will be followed-up after screening during a period of 12 months post-grafting on 3, 6, 9 and 12 months after initial grafting.]
- Endocrinological (hormonal) study [Time frame: Each patient in the study will be followed-up after screening during a period of 12 months post-grafting on 3, 6, 9 and 12 months after initial grafting.]
- Biomarker Study [Time frame: Each patient in the study will be followed-up after screening during a period of 12 months post-grafting on 3, 6, 9 and 12 months after initial grafting.]
- Complications [Time frame: Each patient in the study will be follow-up after screening during a period of 15 months post-grafting.]
Eligibility 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- UZ Brussel Centre for Reproductive Medicine — Brussels
Identifiers
NCT: NCT05414045 · 2019-477