Treatments

UNITY Trial – UNexplained InfertiliTY treatment Trial

A randomised controlled trial evaluating the clinical and cost effectiveness of IVF versus IUI for unexplained infertility.

Infertility, defined as the failure to conceive after 12 months or more of regular unprotected sex, affects 1 in 7 couples in the UK, and unexplained infertility (UEI) affects 30% of infertile couples. The current UK treatment for UEI is in vitro fertilisation (IVF). Whilst IVF can overcome unexplained infertility in some couples, it is an invasive and expensive treatment, with associated procedures having potential side-effects and costing around £5000 per attempt. A less invasive, cheaper, alternative treatment is intrauterine insemination (IUI), where sperm are inserted into the uterus, increasing the chance of a sperm fertilising the egg. To address this question of whether 3 cycles of IUI is an appropriate alternative to one cycle of IVF for couples with UEI, in the ethnically, socially and economically diverse UK population, we have designed the UNITY Trial.

This multi-centre, multi-specialism trial will provide the rigorous evidence required to evaluate these treatment options; assessing value for money, feasibility, safety, appropriateness, and patient and ethical acceptability throughout the process. Patient and Public involvement will incorporate multilingual social media and infographic strategies to ensure the widest-possible audience and impact.