Testicular Tissue Cryopreservation in Children

Testicular tissue cryopreservation is currently considered experimental but offers the only
opportunity for fertility preservation in pre-pubescent boys faced with a fertility
threatening diagnosis or treatment plan.

Inclusion Criteria: (All inclusion criteria must be met.)

1. Be male 0-17 years of age.

2. Meet at least one of the following four conditions:

a. 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. Risk categories based
on treatment regimens are indicated below. Investigators will utilize three sources to
calculate risk: 1."Fertile Hope - Risks of Azoospermia" brochure that details typical
agents and treatment regimens in each risk category, 2. the Summed Alkylating Agent
dose score, or 3. the Cyclophosphamide Equivalent Dose method. Because of the
complexity of many treatment regimens, patient risk categorization will be at the
discretion of the investigators.

i. High Risk (1. ≥80% risk of prolonged azoospermia, Fertile Hope Brochure; 2. Summed
alkylating agent dose score ≥3; 3. Cyclophosphamide equivalent dose ≥7,500mg/m2).

ii. Intermediate Risk (21-79% risk of prolonged azoospermia, Fertile Hope).

iii. Low Risk (≤20% risk of prolonged azoospermia, Fertile Hope).

iv. Eligibility is limited to patients in the High Risk category.

b. Or, have a medical condition or malignancy that requires removal of all or part of
one or both testicles.

c. Or, have a medical condition (genetic or autoimmune) that results in decline in
fertility (e.g. Klinefelter syndrome).

d. Or, have a newly diagnosed or recurrent disease affecting fertility. 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.

3. Have two testicles if undergoing elective removal of a testicle for fertility
preservation only. Note: removal of both testicles will limit fertility preservation
options.

4. 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.

5. Consent for serum screening tests for infectious diseases to be performed at the time
of testicular tissue harvesting. The immediate testing will include but not be limited
to testing for Hepatitis B, Hepatitis C, and HIV.

6. 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.

Exclusion Criteria: (Any exclusion criteria will disqualify.)

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.

3. Previous recipients of gonadotoxic chemotherapy or radiation therapy thought to have
resulted in impairment of testicular function.