Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2020-07-30
2031-07-31
Brief Summary
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Detailed Description
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Female cancer patients express fertility preservation is extremely important for their long-term psychosocial health. The current American Society for Clinical Oncology Clinical Practice Guideline states that all patients should be made aware of possible side effects of treatment on fertility, and that patients be offered fertility preservation interventions. Embryo banking or egg banking (oocyte preservation) prior to chemotherapy is the most successful options for fertility preservation in women. This option necessitates time for ovarian stimulation and retrieval which can take up to 2-3 weeks and is costly. This option may be longer for those who acquire ovarian hyper-stimulation syndrome and younger patients have a higher risk for OHSS. Embryo banking requires mature oocytes and can cause emotional and physical stress. The financial and physical challenges with fertility preservation motivate the desire to find alternatives for young cancer patients.
Improved freezing and thawing techniques for human oocytes have contributed to pregnancy rates comparable to those using fresh egg following in vitro fertilization. Prior to ovarian tissue cryopreservation there was no fertility preservation intervention available to patients who could not delay treatment or were too young to undergo hormonal stimulation. As of 2017, greater than 130 live births following transplantation of frozen/thawed ovarian tissue have been reported. Ovarian tissue cryopreservation has proven to be a safe and efficient method for preserving future fertility for patients undergoing potentially sterilizing treatments. Ovarian tissue cryopreservation is a standard-of-care in parts of Europe and is routine in several children's hospitals throughout the United States. We propose this option be available to qualifying patients at Phoenix Children's Hospital.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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girls facing possible infertility
Newly diagnosed female or relapsed malignancy who is 1-25 years of age 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 alkylator OR health condition or malignancy that requires removal of one or both ovaries
Ovarian tissue removal will be performed laparoscopically
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.
Interventions
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Ovarian tissue removal will be performed laparoscopically
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.
Eligibility Criteria
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Inclusion Criteria
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 Criteria
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)
1 Year
25 Years
FEMALE
No
Sponsors
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Phoenix Children's Hospital
OTHER
Responsible Party
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Locations
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Phoenix Childrens
Phoenix, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Alexandra Walsh, MD
Role: primary
Briana Fodor, BS
Role: backup
Other Identifiers
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19-195
Identifier Type: -
Identifier Source: org_study_id