Purpose:
To propose the milestones that, if met, would support a decision to resume fertility clinic activities and treatments in the UK and to assess which of these can be considered to have been met.

Information gathering process:
A letter was sent to the memberships of the Association of Reproductive and Clinical Scientists (ARCS) and the British Fertility Society (BFS) on 9/4/20 to seek opinions and input into the milestones that must be passed to allow specific areas of our work to recommence. Alongside this, a review of the scientific evidence was undertaken, the evolving National COVID-19 guidance reviewed, and stakeholder and patient submissions were considered.

This document outlines the position of the ARCS and BFS Executive Committees regarding the milestones relevant to the resumption of treatment recently outlined by the Human Fertilisation and Embryology Authority (HFEA) and considers the feasibility and high-level requirements for routine fertility treatments to resume in the U.K. at this stage of the COVID-19 pandemic.

Detailed and best practice guidance for the resumption of treatment services will be addressed in a forthcoming publication by BFS/ARCS.

Background:
In a letter to clinics on 23/4/20 the HFEA outlined their criteria to vary or revoke General Direction 0014, they were:
1. That Government restrictions on social contact and travel are lifted or eased.
2. That restarting fertility treatment would not have a negative impact on the NHS.
3. That there was no evidence that Covid-19 impacted on the health of pregnant women or their babies.
4. That fertility clinics are able to provide a safe service.

These HFEA criteria reflect the original rationale for cessation of treatment services and represent a timely review given the changes in UK COVID-19 patterns and understanding over the period of the pandemic.

ARCS/BFS have considered the HFEA’s published criteria and believe:

1. Restrictions on contact and travel: Once other comparable treatment services recommence and/or restrictions on social contact and travel are relaxed, infertility services should be reopened. Such a policy would be consistent with that already implemented by other European countries such as Denmark and Spain. In addition, the NHS has now entered a second phase of work which includes the reintroduction of some urgent services in hospitals.

2. Impact on the NHS: Since the decision to cease fertility treatments was implemented, the NHS has, thankfully, maintained capacity to cope with the pandemic, and, whilst there are regional differences, much new capacity remains unused. The NHS has now entered a second phase, reintroducing a range of urgent services into hospitals and encouraging the use of primary and emergency care services.

An important consideration should be the avoidance of significant burden on the NHS through the management of complications of pregnancy and fertility treatment. Appropriate care in the use of ovarian stimulation protocols and surgical procedures can reduce these to a level which avoids a significant additional care burden. Any additional burden to the NHS represented by complications of early pregnancies arising from fertility treatment should be viewed in the context of the burden placed by all pregnancies. Fertility treatments account for fewer than 4% of pregnancies in the UK and no advice has been issued by the government to the general public not to conceive natural pregnancies.

The repurposing of fertility clinics, staff and equipment to support the NHS effort to care for coronavirus patients continues. Hence, a further milestone for reopening NHS and Private fertility clinics, should be the release of fertility clinic staff and facilities back from other use ensuring safe staffing levels. Whilst this milestone would not apply to those clinics that have not had their staff or facilities repurposed in this way, but may have furloughed staff, all centres need to ensure that they have sufficient staff available to safely manage the volume of work planned, and contingencies if staffing levels are compromised.

3. Pregnancy and babies: While data remain limited, there is growing evidence that the coronavirus has low impact on early pregnancy and perinatal risk. The RCOG, which is closely monitoring international evidence as it emerges, has now advised that pregnant women do not appear to be more likely to be seriously unwell than other healthy adults if they develop coronavirus. Moreover, they have stated that there is no evidence to suggest an increased risk of miscarriage, and that it is unlikely that if the mother contracts the virus that it would cause problems with the baby’s development, stating that none have been observed thus far (RCOG, Coronavirus (COVID-19) infection and pregnancy – guidance for healthcare professionals: Version 8 – 17/3/20).

4. Fertility clinic safety of services: A key milestone for opening a clinic should be the availability of sufficient staff and equipment to operate a safe and effective service in a way that protects staff and patients from infection risk. An important part of this milestone is the provision of appropriate and sufficient PPE. It also requires caution and comprehensive risk assessment of all treatment services.
A number of professional societies and clinics have issued detailed guidance on how this can be achieved operationally (European Society of Human Reproduction and Embryology (ESHRE) 2020, American Society for Human Reproduction (ASRM) 2020 and ARCS/BFS guidance will follow soon. Clinics should be able to demonstrate the operational steps they have taken to implement suitable systems to address the risks associated with resumption of services. The highly regulated context in which UK HFEA licensed clinics operate will provide assurance to the public and policy makers that implementation of appropriate measures will be undertaken and seen to be so.

Conclusions
On the 18/3/2020 ARCS/BFS published guidance recommending a cessation of elective fertility treatments in the U.K. This guidance was published against the backdrop of a growing and poorly understood pandemic and a well-founded fear that the health service could be overwhelmed with COVID-19 cases. Cases in the U.K. have now likely peaked and stabilised and it seems reasonable to suggest that, until a viable vaccine or treatment is available, a ‘new normal’ will prevail, with some activities being undertaken while social distancing and other mitigation strategies remain in place. With this being the case, as significant delays to treatment can be detrimental to patients with sub-fertility, BFS and ARCS consider that fertility treatment should be permitted at the same time as other serious non-emergency medical conditions. The two societies will provide guidance for reintroduction plans which should consider phasing, social distancing and prioritisation strategies.

In summary, the current view of the ARCS and BFS is that the key milestones against which the HFEA criteria are proposed to be measured have already been largely met or will be in the near future.
However, for clarity, ARCS and BFS have no regulatory authority over the sector and this document serves as a position statement. Any decision to allow fertility treatments to resume in the U.K. can only be taken by the HFEA through the revision or revocation of General Direction 0014 and it is incumbent upon the HFEA to determine the conditions under which any such revision would be made and monitored. When resumption of treatment services is permitted, BFS/ARCS would expect centres to give due consideration to their best practice guidelines which will be published soon.

Dissemination:
This document will be shared with HFEA, RCOG, available on ARCS and BFS Websites and to the public via social media feeds.