Ovarian Tissue Cryopreservation: Users Manual
This manual details the NPC Implementation phase and can be done in parallel with or after completion of the NPC Membership Documents. It can also serve as a reference for general fertility preservation programs.
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
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.
06c. ReproTech forms should be accessed via the NPC-specific URL for EACH PATIENT: http://forms.reprotech.com/npc-oncofertility-consortium.html
Section 7. Sage/Origio: Establishing an Account and Ordering Media
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 Oncofertility Consortium is able to reimburse 24 invoices per grant year (for patients who donate portion of tissue to research). Invoices must be received within 30-days of surgery to be eligible for reimbursement and funds should be dedicated towards lab staff responsible for processing of research tissues sent to the Oncofertility Consortium.
IMPORTANT NOTE: The Adverse Event Log is used for internal tracking of adverse events at your own institution. This log may be shared with the Oncofertility Consortium (email@example.com) annually when you submit your IRB renewal documents but is not required. The Serious Adverse Event Notification Form is used for internal tracking of serious adverse events at your own institution. This log may be shared with the Oncofertility Consortium (firstname.lastname@example.org) at any time during the year for tracking purposes but is not required.
Section 10. Laboratory Procedures and Forms
Training Video: Dissection of a Whole Ovary in Preparation for Cryopreservation