Autologous Transplantation of Human Cryopreserved Testis Tissue

NCT07364409 | Active Not Recruiting

• 3 other identifiers: H-240390982096-00027BP-2024-17175
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Sperm retrieval

  The primary outcome of interest is the retrieval of viable sperm by testicular sperm extraction (TESE) from the transplanted testicular tissue

  Sperm retrieved yes/no at 6 months post transplantation

Secondary Outcomes (3)

• Genetic Stability of retrieved Spermatozoa

  Assessed in sperm retrieved 6 months after transplantation

• Histology of engrafted testicular Tissue

  Tissue retrieved 6 months after transplantation

• Safety of subcutaneous Transplantation

  From obtaining the testicular biopsy until full healing from the procedure for retrieving the transplanted tissue, up to 3 months after tissue retrieval

Study Arms (1)

Autologous Transplantation of Testis Tissue

EXPERIMENTAL

Autologous transplantation of testis tissue under the scrotal skin

Procedure: Autologous Transplantation of Testis Tissue

Interventions

Autologous Transplantation of Testis Tissue PROCEDURE

Autologous transplantation of testis tissue under the scrotal skin

Autologous Transplantation of Testis Tissue

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• University of Copenhagen: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Copenhagen University Hospital - Herlev and Gentofte

Herlev, Capital Region, 2730, Denmark

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Diseases; Infertility, Male; Azoospermia, Nonobstructive

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Elena von Rohden, MD

  Department of Urology, Copenhagen University Hospital - Herlev and Gentofte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: January 23, 2026
• Study Start: November 4, 2024
• Primary Completion: December 17, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)