Testicular Tissue Cryopreservation for Fertility Preservation in Patients with Infertility-Causing Diseases or Treatment Regimens

Inclusion Criteria

• Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with significant risk of causing permanent and complete loss of subsequent testicular function. The Fertility Preservation Program (FPP) employs two methods to calculate the risk of infertility (prolonged azoospermia) in boys/men. The first one is the cyclophosphamide equivalent dose (CED) calculator. Alkylating chemotherapy is the most toxic to fertility and therefore, the FPP uses the CED calculator to determine the risk of infertility from alkylating chemotherapy. Patients with a CED of 4 g/m^2 have significant risk of infertility. Secondly, the FPP uses published data on radiation and other therapies not included in the CED to determine risk of infertility as follows: * Significant risk: ** Total body irradiation (TBI) ** Testicular radiation > 2.5 Gy ** Cisplatin 500 mg/m^2
• 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 Human Services
• Consent for serum screening tests for infectious diseases (human immunodeficiency virus [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 American College of Cardiology [ACC]/American Heart Association [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. Telephone script and email survey are provided

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