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Oxidative Stress as a biomarker for Embryo Selection in IVF Process

Periodic Reporting for period 1 - FERTISSIMO (Oxidative Stress as a biomarker for Embryo Selection in IVF Process)

Periodo di rendicontazione: 2016-03-01 al 2016-08-31

The sentinel issue surrounding multiple gestations and IVF is the inability to precisely estimate the reproductive potential of an individual embryo. Failure rates for IVF remain high. On average, only 25-30% of embryo transfers result in a pregnancy. In addition, the rate of multiple gestations associated with IVF remains high because practitioners continue to perform multiple embryo transfers (MET) to maintain or enhance pregnancy rates. There are significant maternal and neonatal risks associated with multiple gestations. As a result, there is now significant pressure to move towards single embryo transfer (SET), yet currently available technologies are suboptimal and do little to assist the practitioner in responding to this pressure. Therefore, there is a tremendous need for novel biomarkers that will enable the physicians' effective embryo selection - a need for a rapid, non-invasive, and accurate method for assisting in embryo viability assessment
Importance to society: Assisting unfertile couples in achieving pregnancy and having healthy baby will have dramatic contribution to society. One of six couples suffers from fertility problems. Only a small percentage of these couples seek treatment. Infertile couples’ number increases with growing age of marriage, pollution and unhealthy nutrition. In-vitro fertilization (IVF) has been utilized by couples when faced with difficulties in conceiving naturally. Since IVF’s conception and first-usage however, fertilization of an embryo still sits at a lowly 25% rate of fertilization, in spite of multiple embryos being utilized in the procedure to increase the chances of fertilization. Using Fertissimo’s capabilities will contribute to reduced fatality and complications risk to patient and pre-conceived child through the elimination of multiple conceptions (when several IVF transfers are carried out to increase the rate of fertilization); to reduced financial cost to patient and health care system as only a single embryo transfer (SET) would be required, and birthing would be carried out only for a single child.
The main Objectives were: 1) Elaboration of a comprehensive and sound business plan, 2) identification and contact with business and/or technical partners, 3) elaboration of a clinical trials scheme, and 4) elaboration of an industrialization development plan (“Phase 2 implementation plan”).
Carmel Diagnostics performed a thorough feasibility study to examine the product’s ability to succeed in the market. To achieve these objectives we performed: analysis of addressable market demand according to statistics of IVF/ART treatments, considering the willingness to pay (for the patient, insurers, government, clinic, hospital). Calculation of adequate pricing for the developed solution. Assessment of the business viability by conducting a SWOT analysis and building a financial forecast to examine the opportunity. The technical viability was as well assessed for the assay and the device, pursuant to previous studies and validation tests. We built a detailed product development plan for Phase 2 implementation, related to the guidelines set up by medical test regulations and requirements. This included preparing a conformity assessment to the Class I CE mark certification for medical devices. We have also prepared a clinical research plan to further assess and demonstrate the clinical performance of the Fertissimo system. We assessed the procedure and plan to apply to a Notified Body for assessment and certification and to affix CE marking. We perfumed as well a risk assessment and prepared contingency plan. We considered the trend of adapting the concept of SET (Single Embryo Transfer) and its effect on the need for Fertissimo.
The work performed included thorough investigation of the trends in the IVF market, the demand for solutions, interviews with major players, opinion leaders and physicians. We analysed the IP status and made conclusions for the future, analysing the whole picture and prepared financial forecast and detailed working plan. We have analysed the results and as a consequence – decided to continue with the project and build sound working plan and business plan. The company is confident that the product can succeed in the market place following extensive clinical validation studies, either as stand-alone system or as part of combined test together with other technologies.
The state of the art of Embryo Selection is morphology, namely examining the embryo under a microscope during the incubation period. This is subjective; it exposes the embryo to risks and has brings poor results. Producing a method and system to increase the success rate of IVF process through noninvasive tools will push the IVF industry forward, will decrease the overall expenses on the process and will enable couples in developing countries achieve their goal of having baby.