Ovarian Tissue Cryopreservation in Children

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

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

1. Female, age birth-17 years

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

1. Have a diagnosis of a medical condition that is expected to result in permanent
diminished or complete loss of subsequent ovarian function (e.g. Turner's
syndrome) OR have a diagnosis that will create a need for surgery, chemotherapy,
drug treatment and/or radiation for the treatment or prevention of the condition
(e.g lupus nephritis) or malignancy and is expected to result in permanent
diminished or complete loss of subsequent ovarian function. Unlike in males where
a semen analysis provides an objective measure of testicular function, ovarian
reserve testing remains subjective by evaluation of hormones. Therefore, to
objectively qualify a degree of expected diminished loss of fertility is
difficult.

2. Or, have a medical condition or malignancy that requires removal of all or part
of one or both ovaries. Girls with ovarian or germ cell tumors requiring removal
of all or part of one or both ovaries will also be eligible for inclusion in the
study.

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

3. For patients undergoing elective removal of all or part of an ovary for fertility
preservation only, they must have two ovaries.

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.

Exclusion Criteria: (Any exclusion criteria will disqualify.)

1. Girls with psychological, psychiatric, or other conditions which prevent giving fully
informed consent.

2. Girls whose underlying medical condition significantly increases their risk of
complications from anesthesia and surgery.

3. Subjects with extensive disease whose therapy is deemed palliative by the medical
oncologist will not be selected.

4. Subjects with suspected severe diminished ovarian reserve, such as a follicle
stimulating hormone (FSH) level of > 15.