Title: Delivering at-home access to clinical-standard fertility treatment
Funder: Department of Health and Social Care

Abstract: Stepone Fertility's ambition is to reduce demographic, geographic, and economic barriers to accessing fertility treatment. With NIHR support, we will empower people with an innovative safe, effective, affordable first-line clinical-standard fertility treatment suitable for at-home use. Infertility is a global public health issue, experienced by 10-25% of women worldwide (WHO, 2020) and affecting 3.5 million people in the UK (NICE, 2013/2017), with rates rising. Despite this, UK public funding for fertility treatment is declining. Even once requirements are met, patients may wait up to 3 years for IVF treatment. Infertile UK-based couples spend an average of &pound;11,378 on fertility treatment (Fertility Network UK, 2016). IVF is recommended as the clinical first-line treatment (costing &pound;5,000+ per round), although in practice, the clinical first line treatment is often Intrauterine Insemination (IUI), which costs &pound;700-&pound;1,600 per round. For those just beginning their journey, there exist dangerous 'fertility supplements' and unregulated at-home IUI kits (some containing speculums), which are unsafe for non-professionals. It is a chasm of misinformation and chronic stress. It needn't be. A treatment called intracervical insemination (ICI) was once widely available in fertility clinics. ICI concentrates semen onto the cervix using a cup, left in situ for 4+ hours. ICI fell out of favour during the 1980s when IUI became available (enabled by improved semen-processing techniques associated with the development of IVF). IUI is a quicker, more profitable in-clinic treatment option for clinics. Cochrane reviews have shown that ICI has similar efficacy to IUI (Kop et al., 2018). ICI is a proven effective clinical treatment, which is suitable for at-home treatment. It is time to bring ICI back, but this time into the home. We are developing ICI alongside digital technologies, creating a novel combination of leading clinical and digital approaches to create an at-home fertility treatment, Digital-ICI, which is safe, effective, affordable, and inclusive. Our key project aim is to support a usability study required to secure regulatory approval and unlock public funding for Phase II efficacy clinical trials. We will (1) Develop a UK based clinical partnership to support Phase II clinical trials demonstrating Digital-ICI cost-effectiveness; (2) Conduct an initial usability study; (3) Secure regulatory approval and develop Phase II study protocol and monitoring plan; and, (4) Refine our business plan. Involvement of patients during product development is vital. We run regular focus groups, engaging women who are planning and/or struggling to conceive. We have shared initial designs and concepts, gathering user insights following a human-centred design approach. 20 participants will be engaged in the usability study during this i4i Connect project and we will run a larger trial with 150-200 patients in the UK following.

Lay abstract: Stepone Fertility's ambition is to reduce demographic, geographic, and economic barriers to accessing fertility treatment. With NIHR support, we will empower people with an innovative safe, effective, affordable first-line clinical-standard fertility treatment suitable for at-home use. Infertility is a global public health issue, experienced by 10-25% of women worldwide (WHO, 2020) and affecting 3.5 million people in the UK (NICE, 2013/2017), with rates rising. Despite this, UK public funding for fertility treatment is declining. Even once requirements are met, patients may wait up to 3 years for IVF treatment. Infertile UK-based couples spend an average of &pound;11,378 on fertility treatment (Fertility Network UK, 2016). IVF is recommended as the clinical first-line treatment (costing &pound;5,000+ per round), although in practice, the clinical first line treatment is often Intrauterine Insemination (IUI), which costs &pound;700-&pound;1,600 per round. For those just beginning their journey, there exist dangerous 'fertility supplements' and unregulated at-home IUI kits (some containing speculums), which are unsafe for non-professionals. It is a chasm of misinformation and chronic stress. It needn't be. A treatment called intracervical insemination (ICI) was once widely available in fertility clinics. ICI concentrates semen onto the cervix using a cup, left in situ for 4+ hours. ICI fell out of favour during the 1980s when IUI became available (enabled by improved semen-processing techniques associated with the development of IVF). IUI is a quicker, more profitable in-clinic treatment option for clinics. Cochrane reviews have shown that ICI has similar efficacy to IUI (Kop et al., 2018). ICI is a proven effective clinical treatment, which is suitable for at-home treatment. It is time to bring ICI back, but this time into the home. We are developing ICI alongside digital technologies, creating a novel combination of leading clinical and digital approaches to create an at-home fertility treatment, Digital-ICI, which is safe, effective, affordable, and inclusive. Our key project aim is to support a usability study required to secure regulatory approval and unlock public funding for Phase II efficacy clinical trials. We will (1) Develop a UK based clinical partnership to support Phase II clinical trials demonstrating Digital-ICI cost-effectiveness; (2) Conduct an initial usability study; (3) Secure regulatory approval and develop Phase II study protocol and monitoring plan; and, (4) Refine our business plan. Involvement of patients during product development is vital. We run regular focus groups, engaging women who are planning and/or struggling to conceive. We have shared initial designs and concepts, gathering user insights following a human-centred design approach. 20 participants will be engaged in the usability study during this i4i Connect project and we will run a larger trial with 150-200 patients in the UK following.

Research activity codes: 6.3 MEDICAL DEVICES;5.3 MEDICAL DEVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH