Transplanting frozen testicular tissue to restore fertility in men
Autologous Testicular Tissue Transplantation for Fertility Restoration
This study is testing if transplanting frozen testicular tissue can help men who had cancer as boys regain their ability to father children later in life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05414045 on ClinicalTrials.gov |
What this trial studies
This study focuses on the autologous transplantation of cryopreserved testicular tissue from prepubertal boys who have undergone fertility preservation due to cancer or hematologic diseases. The aim is to restore spermatogenesis and fertility in men who experience total azoospermia in adulthood. The process involves analyzing semen and blood to determine the presence of spermatozoa, and if absent, proceeding with the transplantation of the preserved tissue. This innovative approach builds on previous fertility preservation efforts and aims to provide a viable option for men wishing to conceive after treatment.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who had testicular tissue cryopreserved as prepubertal boys and are now seeking to restore their fertility.
Not a fit: Patients who have not undergone testicular tissue cryopreservation or those who do not have azoospermia may not benefit from this study.
Why it matters
Potential benefit: If successful, this could enable men who are azoospermic due to prior treatments to regain their fertility and have biological children.
How similar studies have performed: While similar fertility preservation methods have been implemented, this specific approach of autologous transplantation has not been previously performed, making it a novel endeavor.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels
- UZ Brussel Centre for Reproductive Medicine — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Veerle Vloeberghs, MD — CRG UZ Brussel
- Study coordinator: Veerle Vloeberghs, MD
- Email: veerle.vloeberghs@uzbrussel.be
- Phone: 003224776699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.