Testicular Tissue Cryopreservation for Fertility Preservation

Launched by UNIVERSITY OF PITTSBURGH · Nov 21, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called testicular tissue cryopreservation, which is a way to help young boys preserve their ability to have children in the future, especially when they are facing treatments like surgery, chemotherapy, or radiation for cancer or autoimmune disorders that could harm their fertility. The procedure involves taking a small piece of testicular tissue from the boy and freezing it. This tissue can potentially be used later on when new treatments become available that might help restore fertility.

To be eligible for this trial, boys of any age can participate as long as they are scheduled for treatments that may affect their testicular function or need surgery involving their testicles. Participants will need to sign consent forms and may undergo some health screenings before the procedure. It’s also important to know that the boys will need to be followed up over time to monitor the outcomes. This trial is currently recruiting participants, and it aims to provide hope for young boys who wish to have children in the future despite their current health challenges.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Be male at any age.
• • Be 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.
• • Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles.
• • 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 all or part 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
• • Consent for serum screening tests for infectious diseases \[HIV-1, HIV-2, Hepatitis B, Hepatitis C\], 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 ACC/AHA Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon.
• • Participating in long term follow-up is a requirement of the protocol.
• Exclusion Criteria:
• • 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.