About this trial
Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Pregnancy or a patient who is currently breastfeeding
Trial design
Single group
Treatments tested in this trial
Ovarian tissue removal will be performed laparoscopically
Procedure/Surgeryunder general anesthesia concomitantly with another scheduled procedure if possible. Following removal, ovarian tissue will be shipped to University of Pittsburg Medical Center, Magee-Womens Research Institute for processing. Freezing and storing techniques will be in accordance with FDA regulations for reproductive tissues, guidelines of the American Association of Tissues Banks and any other applicable federal, state and local regulations. The tissue will be carefully separated dividing the cortex from the medulla. The cortex will then be cryopreserved for long term storage. The medulla will be shipped overnight back to the PCH Department of Pathology for histological evaluation. If pathology finds evidence of cancer in the ovarian tissue provided, they may request that all of the patient's tissue be returned to pathology for a more detailed examination, which may eliminate the tissue available for the patient's future use.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of patients who utilize their ovarian tissue and the age at which they use it will be evaluated. The number of patients who elect to have OTC will be analyzed over time to identify trends.
data will be investigated via qualitative analysis.
Sponsors and contacts
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