Testicular Tissue Cryopreservation (TTC)

Recruiting now · Not applicable

Conditions studied: Fertility Issues

In brief

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.

Key facts

Study ID

NCT06387498

Run by

University of Colorado, Denver

People needed

60

Starts

2020-09-28

Expected to finish

2027-12-30

Last updated by the study team

2025-09-16

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male at any age.
• Scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function. Be in significant risk of infertility as defined by:
• Cyclophosphamide equivalent dose (CED) ≥4 g/m2
• Total body irradiation (TBI)
• Testicular radiation >2.5 Gy
• Cisplatin 500 mg/m2
• Bone Marrow Transplant (BMT)
• Or have a medical condition or malignancy that requires removal of all or part of one or both testicles.
• Or have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of testicular function.
• Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options.
• Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.
• Consent for serum tests for infectious diseases [including Hepatitis B Surface Antigen, Hepatitis C Virus (HCV) Antibody, and Human Immunodeficiency Virus (HIV) antigen/antibody screen to be performed at the time of testicular tissue harvesting.
• Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent American College of Cardiology/American Heart Association (ACC/AHA) Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon.

You may not qualify if…

• Patients will be ineligible for participation in this study if they are:
• Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
• Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.

Where it is running

• University of Colorado — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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