*These documents have been updated to un-link protocols from the Oncofertility Consortium. Please use as a guideline when submitting amendments to your IRB or starting a new protocol*
Section 1. Oncofertility Guidelines (including Confidentiality Agreements)
Section 2. Establish your Team; Brand Your Center
Section 3. Review the Equipment and Supplies List
Section 4. FDA Registration
Section 5. Memorial Blood Center: Infectious Disease Testing
IMPORTANT NOTE: If ovarian tissue is removed vaginally, it changes the infectious disease testing that must be done. Tissue that comes into contact with the genitourinary tract necessitates GC and Chlamydia testing.
Section 6. Reprotech: Accounts, Logistics, and Donor Eligibility
06b. Summary of Records (see below documents)
IMPORTANT NOTE: It is up to each site to determine if patients will be tested as anonymous donors. If your site is doing donor eligibility in case the patients must use a gestational surrogate or other methods to establish pregnancy, donor eligibility requirements must be followed to treat the cryopreserved ovarian tissue as though it came from anonymous donor of leukocyte tissue and must undergo donor eligibility determination prior to shipping tissue to ReproTech.
Section 7. Sage/Origio: Establishing an Account and Ordering Media
IMPORTANT NOTE: As of October 16, 2017 sites are responsible for purchasing slow-freeze media themselves (outlined in document below).
Section 8. Clinical Tips: Patient Flow, Tissue Transport, Surgical Removal and Pathology
This section describes typical patient flow, a discussion of how to transport the ovary from the operating room, tips for surgical removal and strategies for providing an adequate sample for examination by pathology.
Section 9. Administrative Forms
IMPORTANT NOTE: The Adverse Event/Serious Adverse Event Logs are used for internal tracking of events at your own institution.
Section 10. Laboratory Procedures and Forms