NCT05414045Recruiting
Autologous Testicular Tissue Transplantation
Autologous Testicular Tissue Transplantation for Fertility Restoration
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 17 Feb 2022
- Start date
- 22 Nov 2024
- Primary completion date
- 29 Jul 2030
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Diseases
- Thalassaemia
- NCT number
- NCT05414045
What you commit to
- Study type: Interventional
- Planned participants: 5
- From 22 Nov 2024 to the primary completion date, 29 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contra-indication for surgery
Other illness
- Risk for presence of malignant cells in the testicular tissue
- Instable psychological condition
Other
- Contra-indication for pregnancy in the female partner
- BMI \> 32
- Heavy smoking (≥10 cigarettes/day)
Who the study is looking for
- 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
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 50 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Brussel Centre for Reproductive Medicine Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.