NCT07364409

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Herlev and Gentofte Hospital · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

As of 2025, more than 3,000 pre-pubertal boys worldwide have cryopreserved immature testicular tissue, and the number of centers offering this fertility preservation option prior to gonadotoxic therapies continues to grow. The most advanced strategy for future fertility restoration is the ectopic autologous transplantation of frozen-thawed ITT, allowing the tissue to mature, initiate spermatogenesis, and ultimately provide sperm for assisted fertility treatments. However, the absence of human data and the preservation of ITT samples for later clinical trials have so far hindered clinical translation. To address this knowledge gap, the investigators will conduct a proof-of-concept study involving five healthy adult participants with normal spermatogenesis who have naturally conceived children and do not desire additional biological offspring. Participants will be recruited from the Department of Urology, Copenhagen University Hospital, Herlev and Gentofte Hospital. During elective hydrocele or spermatocele surgery, testicular biopsies will be collected and cryopreserved. At a later stage, the frozen-thawed tissue fragments will be autotransplanted ectopically beneath the scrotal skin. Over a six-month period, participants will undergo regular follow-up. At the end of this period, the transplanted tissue will be retrieved and evaluated for the presence of sperm. If spermatozoa are identified, their genetic stability will also be assessed. This study will generate essential data on the safety, feasibility, and functional potential of using cryopreserved human testicular tissue for fertility restoration, thereby supporting the advancement of this approach toward clinical implementation.

Conditions

• Cancer
• Hematologic Diseases
• Infertility, Male
• Azoospermia, Nonobstructive

Interventions

Type	Name	Description
PROCEDURE	Autologous Transplantation of Testis Tissue	Autologous transplantation of testis tissue under the scrotal skin

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-12-17
• Completion: 2027-03-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Denmark