To increase the chances of in vitro fertilisation (IVF) pregnancy, multiple embryos are usually transferred; however, this leads to multiple births and lowers the average rate of pregnancy even further. Embryo selection would enable single embryo transfer and improve IVF pregnancy rate.
A medical device for selecting IVF embryos
EU-funded Fertissimo project worked on an innovative solution that measures oxidative stress as a biomarker of embryo quality. “Fertissimo essentially provides a means of quantitatively assessing an embryo’s reproductive potential accurately,” explains project coordinator and CEO of Carmel Diagnostics, Tzali Cnaani. Following oocyte retrieval and in vitro fertilisation, gold standard methods of evaluating embryo quality before transfer rely on morphological characteristics and cleavage rate. However, this approach is subjective and prone to errors. Time-lapse monitoring of cultured embryos allows the digital calculation of the cell-cleavage rate and offers an improvement to morphological observation via microscopy. The Fertissimo approach has revolutionised IVF procedures, enabling physicians to select viable embryos by assessing the oxidative profile of their in vitro culture media within minutes. The device uses artificial intelligence and machine learning for optimisation and continuous improvement.
Oxidative stress as a biomarker of embryo viability
Oxidative stress is caused by an imbalance of reactive oxygen species leading to deregulation of cell signalling, and ultimately, apoptosis. It is characteristic of various healthcare conditions including infertility, congestive heart failure, inflammatory and Parkinson's disease. Measuring oxidative stress is usually a time-consuming and expensive procedure. The Fertissimo medical device employs thermochemiluminescence (TCL) technology, which causes protein and lipid molecular oxidative modification after heating. This heating-induced oxidation emits photons and reflects the in vitro residual oxidative capacity and potential of a biological sample. The correlation between the oxidative profile of follicular fluid and the ability to conceive has prompted Fertissimo researchers to take the technology into the clinic.
Fertissimo performance and future prospects
In collaboration with IVI Valencia, the largest IVF clinics network in the world, Fertissimo performed a pilot study, demonstrating an association of the oxidative status of the early IVF embryo and the chances of implantation. Researchers employ the Fertissimo TCL analyser values to predict embryo viability and the probability of pregnancy. Using this approach, a 20 % increase in conception can be expected. There are more than 3 500 IVF clinics worldwide, undertaking nearly 2 million IVF procedures every year. “With an embryo selection market of USD 500 million, there is a market niche for the Fertissimo technology,” emphasises Cnaani. Improving embryo selection and a patient’s ability to conceive in a given cycle will lower the associated cost and reduce stress for women and their partners. The future roadmap of Fertissimo involves the use of oxidative stress to stratify heart failure patients as well as diagnose and monitor various other pathologies including age-related macular degeneration, Parkinson’s disease and Alzheimer's disease. In addition, measuring oxidative stress can support the assessment of the extent of damage after traumatic brain injury. Current efforts of the Fertissimo partners involve preparation for serial manufacturing, regulatory approval and market launch in non-EU countries such as China and Japan.
Fertissimo, embryo, IVF, oxidative stress, pregnancy, embryo selection, TCL, in vitro fertilisation, embryo viability