Infertility is a reproductive disorder defined by the failure to achieve a clinical pregnancy after ≥12 months of regular unprotected sexual intercourse. It affects 25 million European citizens and 1 in 6 couples globally. Europe’s declining fertility rate, currently at 1.5 children per woman, is among the lowest in the world and is expected to decrease to 1.2 by 2030 – making it a key public health issue in the region. Treatment is dependent on diagnosis: the more complex the reasons for infertility, the more complex the procedure. As the least complex option, intrauterine insemination (IUI) is the standard first-line fertility treatment most frequently used worldwide, especially for unexplained infertility, mild male sub-fertility, cervical mucus problems, erectile dysfunction, vaginismus, retrograde ejaculation and same sex couples. Most doctors recommend up to six IUI attempts before progressing to IVF in applicable cases. Although IUI is an attractive option because it is a minimally invasive, low risk and affordable, typically costing €500-€1000 per procedure (without drug therapy – this price can actually increase to €3000 when one includes medication, monitoring, bloodwork and insemination ), it has a low success rate of 6-12%. Unlike natural insemination, IUI relies upon a sudden deposit of highly concentrated processed sperm into the uterine cavity (bolus), decreasing the window of opportunity for ovum fertilization.
The low success rate of IUI often leads to the early use of high risk, expensive IVF treatment. IVF is a complex, highly invasive procedure involving drug therapy (with possible adverse side-affects) to induce ovulation and close monitoring which help to boost its success rate to 32.2%. Risk factors include ovarian hyperstimulation syndrome, ectopic pregnancy, multiple births, premature delivery and low birth weight. Women undergoing IVF treatment also run a fourfold risk of developing borderline ovarian cancer.
At Fertiligent, we wanted to explore the possibility of developing a first-line infertility solution as safe as IUI but with the success rate of IVF. Muharib, Gadir & Shaw demonstrated that slow release insemination (SRI) is an advanced alternative to regular Intrauterine insemination (IUI) by more than doubling the success rates. This study led to the concept and development of EVIE, our wearable/portable low cost, successful first-line treatment to infertility.
