Embryo viability in ivf process using combined measurement of oxidative stress and proteomic profile with time lapse

A study to develop a device & algorithm to analyze oxidative stress & proteomic profile in a ivf laboratory and investigate and validate the use of both as biomarkers for embryo viability in human ivf and its use as an additional markers to the existing morphokinetics markers provided by time lapse

The purpose of this project is the investigation of new predictive embryo viability algorithms and development of a analysis system to include study variables of oxidative stress and protein expression in cultured embryos suitable for clinical use as markers of implantation. This will require the development of new functionalities and validation of TCL Analyzer for improved embryo selection in IVF process, demonstrating its synergy withTime-lapse systems to create a full-proof solution. This study will follow a successful previous project of our group, supported by the EUREKA program in which a (EmbryoscoperR) machine for time lapse analysis of the cultured embryos was developed. The present study is not the result of the fragmentation of another project or action, but appears to promote more activities and efforts in I+D+i, reinvesting the funds raised, as well as great experience generated through it. Due to the current state of the art, the group who presents the project believed necessary to design more efficient algorithms including more variables such as oxidative stress and proteomic profile that could identify the competence of the embryo. The development of this equipment, which will be complementary to the Embryoscope, will allow competitive advantage ahead of those other technologies recently developed time lapse, which do not consider these markers. IVI Alicante, SL, IVI Valencia, SL, IVI Barcelona, SL and Carmel Diagnostics, LTD have joined in order to develop a new diagnostic tool pioneer focused on non-invasive detection of the best embryo to implant . Being necessary complementarity of the partners to obtain this product. The project will be led by IVI Alicante who will consider the needs and will set procedure to follow between all components of the consortium, necessary to successfully fulfill all the premises. In a previous proof of concept study, conducted by Carmel Diagnostics it was observed that the embryonic competence could be affected by growing conditions, which can cause oxidative stress (ROS). The inclusion of these new markers of embryo competence, will serve to design a strategy for non-invasive embryo selection process based on a new universal algorithmic formula, patentable, that integrates both time lapse and ROS markers, useful regardless of embryonic management conditions that exist in the different IVF laboratories. The success of this project will enable, at a later stage a new collaborative project with the time lapse technology investigators to develop a system that integrates these technologies which make it possible in the future to cover major market by commercializing a combination of time lapse and TCL. We can define several objectives: 1) Business purpose focused on developing a new service based on non-invasive markers of embryo viability of diagnostic value in embryos and in embryo culture medium, which would potentially be applicable to all IVF cycles, and prototype development necessary for the non-invasive analysis. 2) Scientific-technical Objective: - Correlation of oxidative profile, protein expression profile and morphokinetic profile to blastocyst formation - Testing all the transferred embryos with known implantation data (KID_number of gestational sacs match with the number of transferred embryos (Herrero et el 2013) - Design of a new non-invasive strategy based on the combination of oxidative profile, protein expression profile and morphokinetic parameters to be predictive of implantation by using logistic regression analysis to increase success rates. - Design of a new patentable algorithm, with predictable economic benefits. - Achieving a non marketable prototype usable in IVF labs combined with Time-Lapse technology. 3) Medical and Social objective: When this study is completed will begin a prospective clinical study based on a tentative improvement of 15 % in the reproductive outcome . Derived from the successful results of this study may be launching a new diagnostic method pioneered focused on non-invasive detection of best embryo to implant. A better, faster and more precise embryo selection. Noticeable improvement in success rates of pregnancy. Thus, the effectiveness of IVF techniques would increase, reducing the incidence of multiple pregnancies and saving additional costs and inconvenience for patients involves repeated cycles and the high level of anxiety to which they are subjected. 4) Business objective : To place IVI Alicante, IVI Valencia and IVI Barcelona and Carmel Diagnostics as leaders in clinical research in the area of reproductive medicine and supplier of a successful product to ensure the best success rates of assisted reproduction treatment and, consequently , an increase in demand for their services and product.
Project ID: 
9 555
Start date: 
Project Duration: 
Project costs: 
1 270 000.00€
Technological Area: 
Diagnostics, Diagnosis
Market Area: 
Diagnostic test products and equipment

Raising the productivity and competitiveness of European businesses through technology. Boosting national economies on the international market, and strengthening the basis for sustainable prosperity and employment.