A single degree of temperature change inside an IVF lab may be enough to damage a human egg before it is even fertilised. IVF success rates in the UK have stalled at 31% per fresh embryo transfer. One overlooked cause is the brief but sharp temperature drops eggs experience during retrieval and handling—up to 6.4°C even under perfect protocol. These fluctuations can disrupt the meiotic spindle, leading to chromosomal errors that may account for roughly 9% of IVF failures, or nearly 5,000 failed cycles per year in the UK. The average private spend per woman who has a live birth is £11,900; for those who remain childless, it rises to £20,300. Eggcell is a patented pump and chamber system designed to keep eggs at physiological temperature throughout aspiration and examination. This project prepares for a 378-patient randomised controlled trial that will test whether the device improves embryo utilisation rates without sacrificing safety. If successful, Eggcell could reduce the number of IVF cycles needed per live birth, shorten lab workflows, and expand access—particularly important as the average age of women starting IVF in the UK now exceeds 35. The project also prioritises inclusivity, with a patient panel co-designing materials to reach underserved groups such as Black women, whose IVF success rates are 10% below the national average.
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RESEARCH QUESTION Can Eggcell improve oocyte quality and IVF success rates by maintaining physiological conditions during follicular aspiration and examination? BACKGROUND Despite growing demand for IVF, success rates remain stagnant at 31% per fresh embryo transferred. The financial, emotional and health costs of IVF are high, with the average private spend per woman in the UK for whom the outcome is a live birth being £11,900, and £20,300 among those who remain childless. Chromosomal errors are a major factor in IVF Failures, often caused by meiotic spindle disruption. A key cause of this disruption is the non-physiological conditions to which oocytes are exposed during IVF procedures, such as temperature fluctuations. Even when today’s gold-standard IVF protocol is perfectly adhered to, oocytes can be exposed to changes of up to 6.4°C. These non-physiological conditions may be responsible for roughly 9% of IVF failures, or nearly 5,000 failed cycles annually in the UK. Eggcell is patented technology that maintains physiological conditions throughout oocyte retrieval and examination, lowering the number of IVF cycles required for each live birth. Eggcell has been designed to simplify and speed up IVF lab workflows, reducing the long wait time and extending IVF access to more patients. This has never been more important now that the average age of women starting to seek IVF services in the UK is over 35. AIMS AND OBJECTIVES Prepare for the Eggcell-NU (Non-inferior Utilisation) validation randomised controlled trial: Objective 1: Finalise the second-generation Eggcell pump based on PPI and clinical feedback on usability, tolerability, and acceptability, achieving design freeze within this project. Objective 2: Prepare MHRA, HRA, and REC submissions for the Eggcell-NU study at Newcastle Hospitals. Objective 3: Conduct a NHS budget-impact analysis. The project culminates with readiness to apply to regulators for approval to run the 378-patient Eggcell-NU study. The primary outcome is non-inferior embryo utilisation rate compared with standard of care; secondary outcomes include egg recovery and fertilisation rates, pregnancy rates, clinician time savings, and usability by diverse clinical staff. METHODS Foveo will collaborate with Labman Automation to finalise the second-generation hardware, improving usability and manufacturability. Mind over Matter Medtech will lead production of all study and regulatory paperwork. A diverse PPI panel, supported by a patient co-applicant will co-design study participant materials and ensure the study is inclusive and patient-centred. TIMELINES FOR DELIVERY The project will run from September 2025 to April 2026, delivering product design freeze and submission-ready study documentation. KNOWLEDGE MOBILISATION AND IMPACT This project prepares for the Eggcell-NU study that will serve as the pivotal validation clinical investigation for CE/UKCA marking Eggcell. An NHS budget-impact model will be created, supporting future NICE Medical Technology Guidance on Eggcell. Public awareness will be raised via social media, and newsletters shared with IVF charities. RESEARCH INCLUSION A diverse PPI panel will co-design study materials to maximise the study’s inclusivity, prioritising under-served populations like Black women, who experience IVF success rates 10% below the national average. The PPI panel will also co-design the plan and content for disseminating the research to the public.
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