OTC: Updated Users Manual

*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)

01a. Oncofertility Consortium Guidelines

Section 2. Establish your Team; Brand Your Center

02a. Establishing Your Team

02b. Branding Your Center (10/2017)

Additional Branding Resources

Section 3. Review the Equipment and Supplies List

03b. Setting Up Your Programmable Freezer

Section 4. FDA Registration

04. Updating or Establishing Your 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.

05a. Testing for Infectious Diseases (10/2017)

05b. Sample Blood Drawing Request

Section 6. Reprotech: Accounts, Logistics, and Donor Eligibility

06a. ReproTech: Accounts, Logistics and Donor Eligibility Determination (10/2017)

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.

06b1. HCTP SOR DED Not Performed.doc

06b2. HCTP SOR DED Was Performed.doc

06b3. HCTP SOR DED Subsequently Performed.doc

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).

07a. Establishing an Account and Ordering Media from Sage (10/2017)

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.

08a. Typical Ovarian Tissue Cryopreservation Patient Flow (10/2017)

08b. Ovarian Tissue Transport Logistics (10/2017)

08c. Removing an Ovary for Fertility Preservation with Pathology Examination (10/2017)

Section 9. Administrative Forms

09a. Administrative Forms and Their Uses (10/2017)

09b. Web Form: Contact Information

09c. Form 2. Enrollment (10/2017)

09e. Adverse Event Log

09f. Serious Adverse Event Notification Form

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

10a. Laboratory Procedure: Sample Labeling (10/2017)