Autologous Testicular Tissue Transplantation
Recruiting · NCT05414045 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitair Ziekenhuis Brussel
View the official record on ClinicalTrials.gov →Interventions studied
Autologous testicular tissue transplantation of prepubertal frozen testicular tissue
What this trial is about
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.
Who can take part
Age range
18 Years to 50 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- UZ Brussel Centre for Reproductive Medicine - Brussels, Belgium