Testicular Tissue Cryopreservation for Fertility Preservation
Testicular Tissue Cryopreservation for Fertility Preservation
Testicular tissue cryopreservation is an experimental procedure where a young boy's
 testicular tissue is retrieved and frozen. This technique is reserved for young male patients
 who are not yet producing mature sperm, with the ultimate goal that their tissue may be used
 in the future to restore fertility when experimental techniques emerge from the research
 pipeline.
Fertility status has an important impact on the post-treatment quality of life for cancer
 survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow
 transplantation). Semen cryopreservation is an established fertility preserving therapy, but
 is not accessible or appropriate for all men. Currently there are no therapies to preserve
 the future fertility of preadolescent boys. However, new reproductive therapies are under
 development and may one day offer "fertile hope" to those survivors that do not currently
 have access to fertility preserving therapies. Clinical management of fertility threatening
 diseases and treatments must have foresight of the gonadotoxic side effects and the potential
 for infertility. When no established fertility sparing options are available, it is
 reasonable to offer harvesting and cryopreservation of testicular tissue as a possible means
 of fertility preservation.

 This study will harvest testicular tissue from eligible patients. Separate portions of the
 harvested tissue and/or cells will be 1) designated for research and 2) cryopreserved and
 maintained for participating patients as a resource for future elective procedures to attempt
 fertility restoration.
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.