Infertility is a global public health issue, experienced by 10-25% of women worldwide and affecting 3.5M people in the UK, with rates rising. Despite this, UK public funding for fertility treatment is declining. 4% of Clinical Commissioning Groups (CCGs) no longer offer publicly funded fertility treatment. Those that do implement rigid requirements including cut-off ages (starting at 34 years), offer limited numbers of cycles (two thirds only provide one cycle of IVF), and have long waiting times (from several months to 3 years, highly clinically significant in the context of rising infertility with age). Consequently, approximately 70% of fertility treatments in the UK are paid for privately. Couples with infertility spend an average of £13,730 on fertility treatment. 78% of couples go into debt to fund their IVF treatment, and 70% experience financial trauma. StepOne Fertility (trading as Béa Fertility) is working to solve the problem of inaccessible and unaffordable fertility care. We are on a mission to reimagine fertility care, making sure everyone can access the support they deserve to create their family. Our ambition is to bring clinical-grade fertility care into homes around the world with a safe, clinically validated, and effective treatment, which is also affordable and inclusive. Our approach is based on a technique called intracervical insemination (ICI), once widely available in fertility clinics. ICI concentrates semen onto the cervix using a cap, left in situ for 4+ hours. ICI fell out of favour during the 1980s when intrauterine insemination (IUI) became available. IUI is a quicker, more profitable in-clinic treatment option for clinics, yet ICI shows similar efficacy. Crucially, ICI is less invasive than IUI and suitable for adaptation to a home environment. We are developing an innovative fertility treatment that combines a novel ICI device and digital health experience, revolutionising at-home fertility treatment.

This project proposes a solution to the devastating and unfair issue of infertility. We are developing a treatment solution that provides clinical-standard fertility treatment - regulated, safe, affordable, effective - in the privacy of one's home. Infertility is a global issue. The WHO predicts 10-25% of women are affected by infertility(WHO\_2020). Male sperm counts dropped 52% over the past 50 years(Levine\_et\_al\_2017) and 40% of couples struggling to conceive have 'unexplained infertility'(Nandi\_and\_Homburg\_2016). Infertility is still taboo. It's not talked about, or taught in the UK sex education curriculum. Consequently, infertility often stirs feelings of shame or failure(Datta\_et\_al\_2016), exacting a toll on individuals and their relationships. A 2014 Danish study revealed couples are 3x more likely to separate when fertility treatments fail(Kjaer\_et\_al\_2014). In the UK, less than 3% of those experiencing infertility access clinical treatment(LaingBuisson\_2018). NHS-funded fertility treatment is decreasing, leaving many at the mercy of factors such as postcode, BMI and age restrictions, as Clinical Commissioning Groups(CCGs) look to tighten eligibility. Private fertility treatment is prohibitively expensive; infertile UK-based couples spend an average of £11,378 on fertility treatment(FertilityNetworkUK\_2016). Still, people are increasingly caught between societal/career pressures and becoming parents. This leads many women to delay conception until 35+(Harper\_et\_al\_2017), an age at which conception becomes increasingly difficult(Committee\_Opinion\_2008), and when they become ineligible for fertility treatment in half of NHS CCGs. Today, there exists a narrow spectrum of clinical treatment options, ranging from intrauterine insemination(IUI; £700-£1,600/round, requiring up to 12 rounds) to IVF(£5,000+/round). For those who do access clinical treatment, it's highly disruptive, involving frequent trips by both partners to fertility clinics. Some women report that the time spent navigating fertility treatment feels like a full-time job. The majority of people(70%) report some detrimental impact of fertility problems and/or treatment on their relationship(FertilityNetworkUK\_2016). For those without the means to access treatment, many of the alternatives on the market are unregulated and even dangerous. Misleading 'fertility supplements' and at-home IUI kits include speculums and equipment that should be used only by medical professionals. This project builds on work developing a novel concept for artificial insemination treatment and digital health experience engineered to be intuitive and effective; optimised by a clinical embryologist to be used safely at home. With Innovate UK support, we will improve access to fertility treatment, providing infertile UK couples with affordable, safe, effective, and convenient treatment. It's time to empower people to take ownership of their body, fertility journey, and choices.