Italian National Cancer Institute “Regina Elena” IFO-IRE

The Ovarian Tissue Bank (BTO) of IFO is a service within the Gynecology Unit (UOC), located at the Regina Elena National Cancer Institute, part of the IFO institutes in Rome. The Bank began its clinical activity of ovarian tissue retrieval and cryopreservation in August 2017, following the successful completion of a comprehensive validation protocol covering all procedures. This process led to official certification through a collaboration agreement with the Laboratory of Reproductive Biology at Rigshospitalet (Copenhagen University Hospital), which validated and certified the procedures adopted by the Bank. In May 2018, after an inspection conducted in accordance with the “Guidelines for the procurement, processing and distribution of tissues for transplantation purposes (14/09/2016)” and Legislative Decrees 191/2007 and 16/2010, the BTO of IFO IRCCS in Rome (Lazio Region) was officially included in the list of tissue banks certified by the Italian National Transplant Centre (Centro Nazionale Trapianti). Operating under a quality management system, the BTO-IRE ensures full traceability of tissues at every stage, allowing complete reconstruction of their pathway from procurement through processing, quality control, storage, and final distribution to the recipient or disposal. Traceability also includes the ability to retrieve and identify all relevant data related to products and materials that come into contact with the tissues. In parallel with its clinical activities, the BTO is actively involved in research programs focused on the safety of ovarian tissue reimplantation, the investigation of gonadotoxic effects of antineoplastic treatments, and the development of innovative technologies aimed at improving the efficacy and outcomes of ovarian tissue transplantation. To date, the Bank has cryopreserved more than 150 ovarian tissue samples. In 2025, the BTO successfully performed its first ovarian tissue reimplantation, resulting in the resumption of menstrual function three months after transplantation, marking a significant clinical milestone. The Ovarian Tissue Bank benefits from annual financial support provided by the Lazio Region, which is specifically allocated to ensure the operational management and sustainability of the Bank. This public funding supports the organization, maintenance, and delivery of fertility preservation services, contributing to the coverage of costs related to ovarian tissue procurement, processing, cryopreservation, storage, and quality assurance activities. Through this regional funding, the Bank is able to facilitate access to fertility preservation services within the public healthcare system, helping to reduce the financial burden on patients and to ensure continuity and high-quality standards of care.