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

Descripción del proyecto

Selección de embriones viables para la fecundación «in vitro»

Las bajas tasas de embarazo durante los procedimientos de fecundación «in vitro» (FIV) se deben a la falta de tecnología para evaluar la viabilidad de los embriones para la transferencia. La práctica actual de transferencia múltiple de embriones es un procedimiento costoso asociado a muchos riesgos, con una tasa media de éxito de solo uno de cada cuatro. La empresa Carmel Diagnostics, de Israel, ha desarrollado y validado un innovador dispositivo que utiliza biomarcadores de estrés oxidativo para la selección de embriones viables en un procedimiento rápido y no invasivo. El objetivo del proyecto Fertissimo, financiado con fondos europeos, es llevar a cabo una serie de estudios de validación clínica retrospectivos y prospectivos para cualificar el novedoso biomarcador para la predicción precisa de la viabilidad embrionaria. Esto sentará las bases para embarazos mediante FIV fiables en el futuro.

Objetivo

Low rates of pregnancy in IVF procedure 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, there are increasing trends have been adopted to accommodate single embryo transfer (SET). SET however, requires more efficient embryo selection tools than current legacy morphology methods.

Fertissimo utilises a novel biomarker of oxidative stress (OS) qualities that will enable the physician’s selection of viable embryos in a rapid, non-invasive, and accurate manner. Fertissimo will provide a quantitative assessment of an embryo’s reproductive potential based on the oxidative profile of its incubated culture media. It will increase IVF pregnancy outcomes by an unprecedented 25% and beyond.

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. Carmel Diagnostics will conduct a series of clinical validation studies, both retrospective and prospective, in order to qualify the novel OS biomarker to effectively predict embryo viability

Carmel Diagnostics (established in 2009) joins forces with Aran R&D, a leading engineering and product development company, forming a solid basis with all necessary knowledge capabilities, infrastructure and finances to support the innovation project. This would allow Carmel, and Aran, to develop, test, certify, and create the production line required for Fertissimo’s 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