UNiTY - The UNexplained InfertiliTY treatment Trial
Research type
Research Study
Full title
A randomised controlled trial evaluating the clinical and cost effectiveness of Intra Uterine Insemination versus In-Vitro Fertilisation for unexplained infertility.
IRAS ID
314070
Contact name
Jackson C Kirkman-Brown
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
5 years, 2 months, 30 days
Research summary
Infertility can have a major impact on couples who wish to have a baby. One third of all infertile couples have a diagnosis of unexplained infertility, with no clear reason found. The treatment is most commonly in vitro fertilisation, or IVF.
IVF fertilises an egg with sperm outside the body to form an embryo (the earliest stage of a baby). There are risks with IVF such as infection, bleeding during the egg collection and risk of ovarian hyperstimulation syndrome. This is where an unexpected and large response to injections leads to too many eggs developing in the ovaries. This can result in the ovaries releasing chemicals which cause liquid to leak into the tummy and in severe cases, the lungs.
Intrauterine insemination (IUI) involves directly inserting sperm into a woman’s womb. Overall it is a simpler treatment than IVF, with fewer expected complications.
Current UK (NICE) guidance only recommends IVF for unexplained infertility, but this is based on previous research with unclear results. Since then, some research suggests that three cycles of IUI may offer the same chance of a healthy baby as one cycle of IVF. IUI may also be more cost effective for couples.
To find out which treatment is best for couples with unexplained infertility we would like to carry out a study called a randomised controlled trial. Couples will have either one IVF cycle or up to three IUI cycles. The two treatments will be compared to see which is more likely to lead to a healthy baby.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
24/EM/0003
Date of REC Opinion
13 Feb 2024
REC opinion
Further Information Favourable Opinion