Male Fertility and Sperm Cryopreservation

RATIONALE: In June 2006, the American Society of Clinical Oncology published a series of
recommendations on fertility preservation for patients with cancer, concluding that "To
preserve the full range of options, fertility preservation, approaches should be considered
as early as possible during treatment planning". These guidelines reflect the greater
attention that has been given in recent years to the fertility complications that can occur
as a result of cancer treatment (eg, chemotherapies and radiation).

Different cancer treatments such as cytotoxic therapy can lead to azoospermia and sterility
for an unknown period. Whether the type of cancer significantly affects semen quality or not
is under debate. In some studies, semen quality of cancer patients did not differ
significantly from those without, but other studies have indicated a significant decrease in
sperm quality in some malignancies such as testicular cancer and Hodgkin. Fertility and
reproductive function are the principal concerns in 80% of successfully treated men with
cancer. Although cancer survivors can become parents by adoption or gamete donation, most
would prefer to have biologic parenthood and biologically related children.

POPULATION: Adult and post-pubertal males, 13 years of age or older, presenting to our clinic
because diagnosed with cancer, who wish to preserve their future fertility. If minors,
parents or guardians have to give consent to the procedure while the boys give their assent.

DESIGN: This is a prospective observational cohort study.

PROCEDURES: Subject Recruitment and Screening Subjects will be recruited by referral from the
Memphis area cancer centers and physicians whose patients express the desire to have
pre-treatment sperm cryopreservation. Minors will be recruited by referral from the St. Jude
Children's Research Hospital (SJCRH) and Methodist-Le Bonheur physicians. These subjects will
undergo an informed consent process in accordance with University of Tennessee Health Science
Center and SJCRH Institutional Review Board. If the five years of storage are up before
subjects are ready to claim it, it will be their responsibility to keep the account open by
paying a fee of about $300.00 per any additional year in storage. If they withdraw from the
study before the five years are up, they will be free to claim the sperm from storage or to
leave it there until the five years are up. Afterwards, they will be responsible for the
annual fees.

Long term Semen Freezing :

After freezing, sperm samples will be sent to FairFax Cryobank in Austin, Texas for long-term
storage. A storage agreement plan has been pre-arranged with FairFax and University of
Tennessee Medical Group.

Follow-up clinical information will be collected only when patients return for fertility
treatment, if coming to our facility.

No follow-up evaluation will be performed if the patients decide to have their specimens
shipped to their new hometown or fertility clinic. However, patients will be asked to contact
the investigators regarding their serum/tissue sample use and fertility outcomes. If no
contact in this regard is made, patients will be re-contacted by the investigators once every
year, if at that time they are 18 years old, or older, and if the five-year storage has
expired.

Inclusion Criteria:

- male, aged 13 years or older,

- diagnosed with cancer, but not yet undergoing therapy

- willing to participate in this clinical trial

- signed Informed consent document

Exclusion Criteria:

- under 13 years old

- have already begun Chemo or radiotherapy