Ovarian Tissue Cryopreservation
Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen
Phoenix Children's Hospital
40 participants
Jul 30, 2020
INTERVENTIONAL
Conditions
Summary
Ovarian Tissue Freezing For Fertility Preservation In Girls Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen
Eligibility
Inclusion Criteria8
- Newly diagnosed or relapsed malignancy with proposed treatment regimen containing at least ONE (1) of the following:
- whole abdomen or pelvic irradiation
- total body irradiation
- Proposed treatment regimen to include any of the following:
- cyclophosphamide equivalent dose (CED, see Green et al 2014) ≥7.5 g/m2
- any treatment regimen containing procarbazine
- bone marrow transplant conditioning regimen containing alkylators
- OR health condition or malignancy that requires removal of one or both ovaries. Health status adequate to undergo elective laparoscopic surgery (as per anesthesiologist assessment)
Exclusion Criteria4
- Pregnancy or a patient who is currently breastfeeding
- Patients who are eligible for and agree to oocyte preservation
- Anyone deemed high risk for complications from the surgery and/or anesthesia.
- Anyone unable to provide consent due to psychiatric conditions or cognitive delay (in parent/guardian for patients <18 years, and patient >18 years)
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Interventions
under 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.
Locations(1)
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NCT06710769