Expert comments

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.

Four experts commented on this briefing. All experts were familiar with similar lateral flow tests. None of the experts had used Proov Confirm before.

Level of innovation

The experts agreed that Proov Confirm is novel and innovative, especially with the convenience for people to test at home, the non-invasive nature of the technology and the ability to provide an immediate result on ovulation occurrence. They noted that it uses simple technology in a new way to provide clinical information without the need to visit the hospital for a blood test. One expert said that the possibility of testing over a 4‑day period rather than a snapshot single blood test allows for better detection of progesterone and therefore improves accuracy.

Potential patient impact

The experts said that the potential benefits of Proov Confirm include:

  • fewer hospital visits

  • less invasive treatment

  • quicker diagnosis of an anovulatory cycle

  • immediate treatment adjustments

  • signposting to relevant fertility services.

One expert said Proov Confirm can provide repeated reassurance for people that they are ovulating.

Two experts said that in addition to Proov Confirm being used to confirm ovulation, it also provides invaluable information about luteal phase health. One expert highlighted the importance of this for in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) treatment cycles. The expert said that there is the potential for people to have progesterone treatment when a luteal phase defect has been identified, which may increase IVF success rate.

Potential system impact

All experts believed that Proov Confirm could replace standard care to confirm ovulation. One expert noted that serum progesterone results received a couple of days after the blood draw, as is the case in most NHS hospitals, are no longer useful. Another expert said that Proov Confirm represents a significant improvement on current NHS testing. Two experts agreed that Proov Confirm is likely to cost less in terms of staff, equipment and care setting needed. One expert noted that it is difficult to estimate the cost savings without a health economic evaluation.

General comments

The clinical experts said that, overall, there were no potential issues or adverse events related to using Proov Confirm. All clinical experts agreed that Proov Confirm could benefit most of its target population, including people with delayed conception, people requiring assessment of ovulation as part of fertility investigation, and people having IVF, particularly those with frozen embryo transfers.

One expert noted that the use of first morning urine to measure progesterone levels limits the effect of the diurnal variation and pulsatile release of progesterone, potentially making Proov Confirm more accurate than a serum progesterone blood test. One expert identified that the technology could be of interest to other specialists such as endocrinologists and physiologists.

Two experts said that the current level of evidence cannot verify the claims that Proov Confirm could help people to get pregnant faster, prevent early miscarriage and increase the chances of successful implantation. Three experts said that further larger-scale research is needed, including research on its accuracy, efficacy and validity. One expert noted that research is needed in people not currently being treated with ovulation-inducing agents. One expert found it difficult to consider the results as robust.