Testicular Tissue Cryopreservation (TTC)

Launched by UNIVERSITY OF COLORADO, DENVER · Apr 25, 2024

Keywords

ClinConnect Summary

The "Testicular Tissue Cryopreservation" study is investigating a method to help preserve fertility for men who may face infertility due to certain medical treatments, like chemotherapy or radiation. This trial is aimed at males of any age who are undergoing treatments that could harm their ability to have children in the future. For some patients, this method of freezing testicular tissue might be the only option available to help protect their fertility.

To be eligible for this study, participants must be male, scheduled for specific treatments that pose a risk to their fertility, and have at least one healthy testicle. They will need to sign consent forms and undergo health screenings before participating. If chosen for the study, patients can expect to have a small piece of testicular tissue collected and frozen for potential future use. It’s important to note that this is a non-surgical procedure aimed at preserving fertility options for patients facing serious health issues.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male at any age.
• 2. 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)
• • 3. Or have a medical condition or malignancy that requires removal of all or part of one or both testicles.
• • 4. 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.
• • 5. Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options.
• • 6. 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.
• • 7. 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.
• • 8. 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.
• • Exclusion Criteria
• Patients will be ineligible for participation in this study if they are:
• • 1. Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
• • 2. Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.