CORDIS - EU research results
CORDIS

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

Project description

Selection of viable embryos for IVF procedure

The low rates of pregnancy during in vitro fertilisation (IVF) procedures are due to a lack of technology to evaluate the viability of embryos for transfer. The current practice of multiple embryo transfer is a costly procedure associated with many risks, averaging a success rate of only 1 in 4. Carmel Diagnostics in Israel has developed and validated an innovative device to use oxidative stress biomarkers for the selection of viable embryos in a rapid, non-invasive procedure. The goal of the EU-funded Fertissimo project is to conduct a series of retrospective and prospective clinical validation studies to qualify the novel biomarker for accurate prediction of embryo viability. This will lay the foundation for dependable IVF pregnancies in the future.

Objective

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

Call for proposal

H2020-SMEInst-2016-2017

See other projects for this call

Sub call

H2020-SMEINST-2-2016-2017

Coordinator

CARMEL DIAGNOSTICS LTD
Net EU contribution
€ 1 446 486,00
Address
9 BARLEV HAIM STREET
3608267 QIRYAT TIVON
Israel

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
€ 1 486 486,00

Participants (1)