Low rates of pregnancy is due to being unable to identify viable embryos for transfer. As a result, multiple embryo transfer (MET) is practiced to increase the chances of pregnancy. This is a costly procedure with riskier outcomes, which on average only equates to a 1 out of 4 rate of pregnancy success. In order to minimise the cost and risk outcomes with MET, methods have been adopted to accommodate single embryo transfer (SET). However, this has been notorious in lowering the average rate of pregnancy even further (<20%). As a result, the overall goal of the project is to help develop, produce, validate, and commercialise the Fertissimo device. A embryo selection device that will help IVF patients significantly improve their chances of pregnancy conception through a single embryo transfer (SET). There is follow on health fall-out risk when including multiple gestation commonly found in current MET practices in existing IVF procedure.
The importance of clinically and commercially achieving this goal will help significantly with healthy, cost-reduced, single births, for patients who are already considered more vulnerable in terms of conceiving because of needing to go through IVF procedure (and not conceive naturally).
The Phase 2 project’s ultimate aim is to lay the foundation for dependable IVF pregnancies of the future. Fertissimo will set the gold standard for IVF procedure in all relevant IVF facilities, located in hospitals, medical centres, centres of IVF excellence, and clinics. The outcome of the innovation project would allow Carmel, consortium partner Aran, and the rest of project value chain to develop, test, certify, and create the production line required for mass production. The industrially produced Fertissimo can then be qualified in a conclusive clinical trial with Global IVF Leader IVI Valencia to the benefit of soon-to-be mothers participating in the trial. The collected data from the clinical trial will verify and validate the technical information required for CE mark attainment. These qualified results will also be used in the dissemination process with the existing 5 IVF-related (culture medium) medical companies, as well as other related stakeholders who would benefit from Fertissimo’s uptake.
