Annually, over 48.5 million couples experience infertility worldwide. Nowadays, reproductive technologies such as In Vitro Fertilization (IVF) are used to overcome this challenge. During IVF treatment embryos produced from fertilized eggs are cultured for 3-5 days in vitro before being either transferred back to the woman's womb or frozen for a later transfer. During culture, embryos can be exposed to detrimental components of their environment, such as adverse temperature, pH and oxygen that can negatively affect the embryo's quality (ability to develop). These exposures reduce the potential for embryo implantation in the uterus and pregnancy and may impact on the baby's health. In the UK ~3.5 million patients undergo infertility treatment/year with busy clinics completing 5,000-10,000 embryo cultures/year/clinic. In more than 100 interviews, embryologists and clinical experts expressed a clear need to improve treatment success by improving efficiency & safety of embryo culture. The NHS currently reports that the percentage of IVF treatments resulting in a live birth in 2019 was 32% for women under 35\. Our IVFmicro device aims to improve embryo culture by better mimicking the natural environment which will support the development of higher quality embryos and ultimately increase the success rate of the IVF treatment. This project will finalise the design of our IVFmicro device, in accordance with clinical need, practice, quality, safety and regulation. A quality management system will be established to prepare all technical documentation for a first pre-submission to the Food and Drug administration, two key steps to make sure the microfluidic device, the material and the manufacturing process, are not only effective but also safe for patient use. With the support of the Health Innovation Networks (HINs) and in particular HIN Yorkshire and Humber, we will engage with the NHS procurement process and Integrated Care Systems to align our technology with NHS clinical needs, reimbursement models, and health economics to demonstrate cost-effectiveness and patient benefits. The HIN will also help us design clinical studies, set up trials, and collect real-world evidence to support adoption by connecting us with clinical research networks, NHS trusts, and IVF clinics. Their support is essential for product scaling and adoption into the NHS, by preparing NICE evaluations and adoption frameworks to gain NHS endorsements and by developing case studies that demonstrate impact. With our operational team, at project end, we will be able to fulfil the requirements for commencing clinical testing of our technology with human embryos.

48.5 million couples experience infertility worldwide annually. Nowadays reproductive technologies and In Vitro Fertilization (IVF) help overcome this challenge. During IVF treatment, a fertilized egg (embryo) is cultured in the laboratory for 3-5 days in vitro before being either transferred into the woman's womb or frozen for a later transfer. During this culture period, the embryo can be exposed to detrimental external stimuli, such as changes of temperature, pH and oxygen that can negatively affect its "quality" (ability to develop). This can reduce the potential of an embryo to implantation in the uterus and produce a pregnancy and many impact on the baby's health. The NHS currently reports that the percentage of IVF treatments that resulted in a live birth in 2019 was 32% for women under 35\. Our IVFmicro device aims to improve the embryo culture procedures by mimicking the natural environment which will support the development of higher quality embryos and ultimately increase the success rate of IVF treatments. With this project, we will complete the design of our IVFmicro device, in accordance with the clinical practice and regulations. With the manufacturer, we will prepare the technical documentation: this is a key step to make sure the microfluidic device, the material and the manufacturing process, are not only effective but first of all safe for the patient. Finally, we will train the first group of clinical expert embryologists to use IVFmicro, and will use their feedback to prepare our device to enter the clinics in 2027\.