Clinical trial · Interventional
Autologous Testicular Tissue Transplantation
Autologous Testicular Tissue Transplantation for Fertility Restoration
NCT05414045CI-TRIAL-00109253recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hematologic Diseases | — | UNRESOLVED | — |
| Sickle Cell Thalassemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous testicular tissue transplantation of prepubertal frozen testicular tissue | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients
- interventionNames
- Procedure: Autologous testicular tissue transplantation of prepubertal frozen testicular tissue
Primary outcomes (1)
- measure
- Restoration of spermatogenesis and fertility by performing an autologous testicular tissue transplantation. Primary endpoint is the presence of spermatozoa in the graft.
- timeFrame
- Graft-removal of intratesticular and intrascrotal grafts is planned 12 months after grafting.
- description
- 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.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.