Summary

Summary

  • The technology described in this briefing is Proov Confirm. It is a lateral flow test designed to confirm ovulation by detecting pregnanediol‑3a‑glucuronide (PdG), the major metabolite of progesterone, in the first morning urine during the luteal phase of the monthly reproductive cycle.

  • The innovative aspects are that Proov Confirm is a non-invasive home test that tracks a progesterone marker to confirm ovulation quality. Compared with standard care, which is a single blood test, Proov Confirm provides an overview of PdG hormone levels over a 4‑day period with instant results. The company says it is designed to help pregnancy happen faster.

  • The intended place in therapy would be as an alternative to a blood test for confirming ovulation.

  • The main points from the evidence summarised in this briefing are from 3 studies, including 2 prospective observational studies (1 of which was a pilot study) and 1 retrospective pilot study, including a total of 226 people. The studies suggest that Proov Confirm may be an effective technology for confirming ovulation.

  • Key uncertainties around the evidence or technology are that there is limited evidence and none of the published studies were based in the UK. There is also no randomised study comparing the technology to standard care or to a similar technology.

  • Experts advised that Proov Confirm is a novel technology that is less invasive and convenient for people to self-test at home without the need for clinic visits, and it provides an immediate result for confirming ovulation. They noted that evidence is limited, and they advised that large-scale studies are needed on its accuracy, efficacy and validity before routine adoption in the NHS.

  • The cost of Proov Confirm is £24.99 per pack of 5 tests (excluding VAT) per month of testing. The cost of a standard care blood test is £1.85.