NCT06387498

Testicular Tissue Cryopreservation (TTC)

Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

The "Testicular Tissue Cryopreservation" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the feasibility and acceptability of testicular tissue cryopreservation in male patients of all ages who have a condition or will undergo a treatment that can cause infertility.

Detailed description

For male patients who currently have no options for fertility preservation, this research proposal will enable optimization of testicular tissue procurement and processing, cryopreservation, and diagnosis/elimination of malignant cell contamination to ensure safety for future fertility-restoring treatments. While results from animal models and human organ donor experiments support the efficacy of testicular tissue/cell cryopreservation for fertility preservation and subsequent restoration, rigorous safety and efficacy data in human patients who will undergo infertility-causing therapies is lacking. However, the patients being recruited for this study currently have no options for future therapies aimed at fertility preservation without the preservation of their testicular tissue/cells prior to treatment. Thus, the current study will provide a potential resource for future fertility restoration.

Conditions

• Fertility Issues

Interventions

Type	Name	Description
PROCEDURE	Testicular tissue biopsy and cryopreservation	Surgical Procurement of Testicular Tissue: At early stages of technology development, simple orchiectomy (removal of one entire testicle) may give the best chance of preserving sufficient cells for effective therapy. However, incisional biopsy of up to 25% of tissue from one testis (wedge resection) will also be presented to the patient as an alternative option. The amount of testicular parenchyma removed will be at the discretion of the surgeon.

Timeline

• Start date: 2020-09-28
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2024-04-29
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States