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A ground-breaking medical system selecting the most viable embryo for successful IVF pregnancy

Periodic Reporting for period 3 - Fertissimo (A ground-breaking medical system selecting the most viable embryo for successful IVF pregnancy)

Reporting period: 2019-05-01 to 2020-04-30

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.
The core indications reported were the relook of the overall Fertissimo device's functionality and user flow. This includes the improving the functionality of various modules. Having decided to apply reengineering and taking care of more than the mentioned modules. Changing the concept of cuvettes and cartridge to a disposable “Tray” with embedded cuvettes in it to test all the embryos of the same patient, drove additional engineering needs and extended the scope and increased the cost of a manufactured unit. We believe that it dramatically improves the usability of the system, its robustness and accurate operation

In terms of the PMT components, we analysed and considered in every aspect where wave length is involved, such as type of protecting glass and reference light source to be used in the calibration process, to achieve optimal response. The optimisation of the PMT data display will be planned for implementation in Q3 2018.

For Shaker operations in the device, we re-designed to optimise operation module to achieve unified fluid distribution on the cuvette’s face, enabling even distribution of culture media. According to a new work flow methodology, it was decided, to use manual spreading of the fluid over the cuvette. After thorough research we decided to use “quadloops” (used in biotechnology application) which showed substantial advantage over mechanical shaking. The advantages are in the unified layer level combined with the user visual audit and judgement of the quality of the sample spreading operation.

Among the other core re-engineering designs, we also had to improve the process to achieve reliability and repeatability of data readings for robust results. All information of work conducted are found within the Technical Report.
The re-engineering principles will ensure the extreme usability of the finished device, as compared to previous incarnations. This was done in close collaboration with key end-user stakeholder IVI Valencia. Proving the importance of creating a product that will actually be used, and not bog down the professionals involved in the IVF process. These key pieces of feedback have been incorporated into the final critical design review for all hardware components, as we move on to software's critical design review. Coupled with the game changing ability of the device's filtering of most promising embryos, the usability question will only enhance its beyond the state of the art status for adoption in IVF clinics globally.