Infertility, affecting one in every six couples worldwide, is on the rise due to factors like delayed childbearing, lifestyle, chronic conditions, and environmental influences. In assisted reproduction, In Vitro Fertilization (IVF) is increasingly preferred, with growing awareness and demand. Egg Freezing procedures are also gaining popularity among younger generations, indicating a rising demand for IVF in the future. Despite nearly a million IVF cycles performed annually in Europe (3 million globally), only 40% result in pregnancy. This low success rate extends the process to an average of three cycles, with each costing around 10,000 euros, creating financial burdens. Emotionally, the journey can be devastating, with a 50% dropout rate among patients.
In high-income countries, high costs and limited healthcare coverage contribute to healthcare inequity, particularly for single individuals, those in same-sex relationships, and women facing secondary infertility. Meanwhile, in low and middle-income countries, IVF is often entirely out of reach due to prohibitive costs, lack of financing, and inadequate services. The disparities in accessing infertility treatments represent a marked social injustice, amplifying the burden on women.
One of the leading causes of IVF failure is embryo transfer (ET), with a live birth rate below 30%. The success of ET hinges on two key factors: embryo quality and endometrial receptivity. While advancements have been made in selecting high-quality embryos, assessing the uterine readiness for ET remains a challenge. Currently this assessment relies on counting days, assuming a synchronic development between the embryo and the endometrium. Ensuring greater accuracy in detecting uterine receptivity and achieving embryo-uterine synchrony are pivotal for enhancing embryo implantation rates and overall IVF success. To meet this urgent and unmet clinical need, we have developed Seedchrony: a groundbreaking medical device specifically designed to non-invasively and immediately detect uterine readiness for embryo transfer. Our vision is to advance reproductive health rights by making IVF treatment more accessible and affordable.
The primary goal of the project, financed by the Women TechEU grant, was to gain understanding and clarity in three strategic pathways within the medical device industry: IP protection, regulation, and clinical investigation. This knowledge was essential for the strategic planning and execution of these pathways.
