The Health Secretary's announcement on 1 May 2020 that fertility services in the UK could apply to reopen (see BioNews 1045) was a message of hope for all those who depend on fertility treatment for having a baby. Around the same time, various national and international scientific fertility societies published guidance on the 'safe' restart of the services during the coronavirus pandemic.
Fertility clinics in the UK had therefore the rather straightforward task of re-designing their practice protocols according to this COVID-19 guidance. Or perhaps this was not so straightforward?
As the medical director of a group of fertility clinics in the UK, I was assigned to design the new coronavirus-proof practice for my group. However, after starting to read the published guidelines, I soon realised that their recommendations were not as aligned as anticipated.
True, some of the recommended practice points were similar - mainly the use of social distancing and the use of personal protective equipment (PPE) by clinical staff. On the other hand, the guidelines approached the topic of testing for COVID-19 in their own different ways. For example, the European Society for Human Reproduction and Embryology (ESHRE) guidance recommended testing only for individuals who have symptoms or have had contact with someone with symptoms of COVID-19 infection, while the British Fertility Society and Association of Reproductive and Clinical Scientists (BFS-ARCS) advised to routinely test IVF patients for COVID-19, if a test is available.
When I investigated the availability of testing, I found out that indeed testing is available, but one had to research which tests are more reliable before deciding which one to go for. Moreover, the logistics of ordering the test, sending the sample to the laboratory and retrieving the result in time for the treatment had to be worked out.
I was so intrigued by the different approaches of the fertility guidelines, which prompted me to author an opinion paper about it, which has now been accepted in a reputable reproductive medicine journal.
Why is there such controversy among the guideline recommendations?
The inconsistencies in guidelines cannot be simply explained by geography. After all, these guidelines come from Europe (including the UK) and North America (USA and Canada), which have been experiencing similar challenges with coronavirus.
The answer is obvious; we simply do not know enough about the virus and we are still developing the relevant tests. More importantly, there is no experience how to best apply these tests in the fertility setting.
Guidance is, therefore, based mostly on expert opinion rather than scientific evidence.
It has to be acknowledged that fertility treatment is unique, in the sense that it lasts for a few weeks, during which one's good health needs to be continually re-affirmed. This is different to elective surgery, where a COVID-19 test can be scheduled just before admission.
One could hope to repeat the COVID-19 test every few days or before every visit to the fertility clinic. However, this is not practical for many reasons. The test often has to be outsourced to an external laboratory and inevitably takes at least a couple of days for the result to be available.
Testing introduces a substantial burden on the fertility services and staff resources, as well as an obvious financial burden for the paying party - whether this is the patient or the health authority.
Another concern has to do with the reliability of the test. No currently available test will pick up 100 percent of COVID-19 cases (current tests have approximately 70 percent sensitivity). This implies that, even if we performed the test repeatedly, we could still 'miss' some of the patients who carry the virus.
The absolute benefit of testing also has to do with how widespread the virus is in the community at any given point in time. At times of low infection rates, the chance of a COVID-19 test being positive is expected to be quite low.
Finally, there are other readily applicable measures, which help to reduce transmission (such as the social distancing and use of PPE); so, even if a patient carries the virus and doesn't know it, this does not mean they will definitely transmit it to others.
So, how should fertility clinics design their COVID-19 protocols for safety?
Until such time when enough experience has accumulated in the fertility sector, each clinic has to make its own decision how to go about it. Since there is no single full-proof test or intervention against coronavirus at the moment, combined measures are warranted. These measures should include social distancing when possible, PPE use, remote appointments, strict sanitation etc. Whether opportunistic COVID-19 testing should be part of the 'artillery' remains up to the individual clinic.
In my opinion, there are reasons for opting to apply more, rather than fewer, anti-COVID-19 measures at the restart.
Firstly, it is presumed to be safer to test, as doing a COVID-19 test can only detect more positive cases than not doing one. This will allow prompt cancellation of the treatment, thereby minimising the risk to others.
Secondly, testing allows the clinic to obtain important feedback on the usefulness of this approach, which could inform future policies. For example, if the test detects positive cases, it is obviously useful and should be continued (or even expanded). If, on the other hand, no positives are detected over a considerable number of sampled patients, this could make an evidence-based argument for discontinuing the test.
If a clinic chooses not to test, they can only learn the hard way, through trial and error; if they experience COVID-19 'clusters', their measures obviously allow enough COVID-19 cases to slip through (a 'cluster' is at least two positive individuals, patients or staff, who have had contact during the fertility treatment).
Other important metrics should also be internally monitored by clinics. The regional trends in infection rates – as published by authoritative bodies - need to be regularly monitored. If the rates increase, it makes sense to tighten the anti-COVID-19 measures, which could include introducing - or re-introducing - a COVID-19 test.
Another important outcome to monitor is for the presence of clusters of positive cases within the same clinic. Clinics should be encouraged to report COVID-19 clusters that occur in their practice to the regulator - the Human Fertilisation and Embryology Authority (HFEA) - together with an action plan how they aim to minimise recurrence by strengthening their COVID-19 protocols.