Clinical trial · Interventional
Autologous Transplantation of Human Cryopreserved Testis Tissue
Restoration of Spermatogenesis by Autologous Grafting of Cryopreserved Testis Tissue From Men With Non-Obstructive Azoospermia and Healthy Men With Proven Fertility
- 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)
For pre-pubertal boys undergoing gonadotoxic therapies, freezing immature testicular tissue (ITT) containing spermatogonial stem cells (SSCs) is currently the only option to potentially preserve future fertility. This experimental clinical study aims to provide proof-of-concept that frozen-thawed, ectopically autotransplanted adult human testicular tissue can support spermatogenesis in healthy adult men.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Azoospermia, Nonobstructive | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hematologic Diseases | — | UNRESOLVED | — |
| Infertility, Male | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Transplantation of Testis Tissue | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous Transplantation of Testis Tissue
- description
- Autologous transplantation of testis tissue under the scrotal skin
- interventionNames
- Procedure: Autologous Transplantation of Testis Tissue
Primary outcomes (1)
- measure
- Sperm retrieval
- timeFrame
- Sperm retrieved yes/no at 6 months post transplantation
- description
- The primary outcome of interest is the retrieval of viable sperm by testicular sperm extraction (TESE) from the transplanted testicular tissue
Secondary outcomes (3)
- measure
- Genetic Stability of retrieved Spermatozoa
- timeFrame
- Assessed in sperm retrieved 6 months after transplantation
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Men referred to the Department of Urology at Herlev and Gentofte Hospital for the treatment of hydrocele or spermatocele were provided with detailed information about the study and invited to participate. Written study information was distributed, and a mandatory reflection period of at least 24 hours was observed prior to obtaining consent. Inclusion Criteria: * Age ≥ 40 years * Scheduled for an elective hydrocele or spermatocele surgery * Willing to have a testis biopsy taken during the planned surgery * At least one biological child, unassisted spontaneous conception * No current or future fertility wishes * Written informed consent for the participation in this study Exclusion Criteria: * Treatment with testosterone substitution * Bleeding disorders that render surgery too high a risk * Other contraindications to surgery * Unable to give informed consent * Language difficulties that could compromise the informed consent or quality of examination
References
Publications (0)
Data not yet available