The British Fertility Society (BFS) and the Association of Reproductive Clinical Scientists (ARCS) have announced new guidelines for fertility patients during the coronavirus pandemic.
UK COVID-19 epidemic continues to escalate.
Whilst pregnant women can be generally reassured they are asked to consider themselves a vulnerable group.
It is expected that UK licenced fertility centres will now be working to suspend treatments.
UK fertility centres must establish the requirements to maintain a minimum service, which may include non-elective fertility preservation.
Centres are expected to keep communication open with patients for advice and reassurance.
Centres are expected to minimise their impact on National Health Service (NHS) resources.
A novel coronavirus infection that can cause serious disease (COVID-19) in a minority of affected people has taken on pandemic proportions, leading to extraordinary measures being introduced across the world.
The situation with respect to the number of affected persons and UK government advice on measures to increase social distancing is evolving. As of 18 March 2020: 56,221 people have been tested in the UK of whom 2662 tested positive for coronavirus, and 104 have died as a result of the illness. The government has advised against non-essential social contact and non-essential travel. Self-isolation has been advised for anyone with symptoms of coronavirus along with their household. The NHS has imposed restrictions on elective surgical and outpatient work, other than in situations where this is needed for the treatment of cancer or the purpose of saving life. The NHS has put in place plans for using medical and nursing staff from different areas in the most efficient way to deal with anticipated patients. This includes block-buying capacity in private hospitals. The aims of these measures are to free-up the maximum possible inpatient and critical care capacity, to prepare for anticipated large numbers of COVID-19 patients who will need respiratory support and to support staff and maximise their availability.
This guidance builds on the initial response from BFS and ARCS to this unprecedented challenge to the UK health system and the health of the population. It is designed to help all UK fertility clinics, regardless of their setting, to prioritise and organise their activities during the outbreak, whilst complying with their clinical, ethical, regulatory and social duties. Few UK licenced clinics will be able to close down completely, since virtually all will have embryos and gametes in storage banks which must be properly maintained in accordance with the law. Centres are advised to plan a flexible local policy which allows for prioritisation and a number of eventualities. Policies must take into account local conditions, breadth of work undertaken and clinic resources (including financial resilience). The overriding priority is for centres to act in a socially responsible manner.
Policies to take into account include the national strategy led by the chief scientific advisor and chief medical officer. Hospital-based clinics will be influenced by their own trust pandemic strategy which is likely to mirror national plans. Clinic groups may develop an overarching strategy, whilst individual centres will need to consider local prevailing conditions.
In developing their local policies, clinics must take into account their duty to abide by regulations arising from the Human Fertilisation and Embryology Act 2008, and laid out by the Human Fertilisation and Embryology Authority (HFEA) in its Code of Practice. HFEA guidance to clinics is available and updated as required. In all this, clinicians retain an ethical responsibility of beneficence and non-maleficence to their patients. A wider social responsibility of promoting public health and preventing harm from infection exists for all citizens, but especially health care providers. All clinics, whether in the state or private sector, should be mindful of their wider responsibilities, including the need to promote social distancing and to consider the potential effects of their work on local NHS services, which are likely to be stretched to an unprecedented extent.
At the time of writing, it is not thought that the infection causes miscarriage or fetal abnormality, and pregnant women do not appear to be at increased susceptibility to the infection or to developing complications. However, in the Prime Minister's bulletin on 16 March 2020, it was made clear that pregnant women were considered a vulnerable group, because this is a new infection and data on effects in pregnancy is limited. Further, there is concern for the potential care commitment required for any pregnant women with symptoms. The question arises whether the benefit of continuing to treat our infertile population may be outweighed by the additional concerns. It is reasonable that women who have risk factors for severe illness if infected, for instance those with diabetes or underlying respiratory disease or immunosuppression, should be advised against conceiving during the outbreak.
Fertility patients with symptoms of COVID 19
Pregnancy should be avoided in women who display symptoms of COVID-19. Patients who are in the stimulation phase of their treatment, but have not yet received the trigger, should be advised treatment cancellation. In such a situation, stopping follicle stimulating hormone (FSH) while continuing with gonadotropin-releasing hormone (GnRH) antagonist (or agonist as the case may be) is likely to protect against ovarian hyperstimulation syndrome (OHSS). Patients should be counselled against unprotected intercourse to avoid the risk of multiple pregnancy.
Patients who have received human chorionic gonadotropin (hCG) or GnRH agonist trigger may proceed to egg collection and freeze-all, if appropriate facilities are available and after a multi-disciplinary assessment of risk.
Patients who develop symptoms after oocyte collection should not have an embryo transfer.
Embryo transfer, or intra-uterine insemination should not be carried out in women with suspected or diagnosed COVID-19.
Stopping treatment programmes
For the reasons above, it is expected that, as the UK epidemic is now proceeding, all centres will stop initiating new fertility treatments, including in vitro fertilisation (IVF), frozen embryo transfer, surgical sperm retrieval, insemination and ovulation induction. This is also in keeping with recommendations from other professional bodies in the field of fertility treatment. When such a decision is made, it is reasonable for clinics to complete treatment that has already commenced in patients who remain well and where the centre's resources allow this to be done safely. However, clinics should be mindful both of their duty to minimise spread and of the impact of any complications on the NHS. Moderate or severe OHSS, which is often managed in an NHS emergency care setting, has been reported in 3.1 to 8 percent of stimulated treatment cycles. The risk of OHSS is reduced by the use of GnRH agonist trigger and freeze-all. It is mandatory therefore to consider these measures in women currently in the process of treatment.
Where resources allow, it is appropriate to continue non-elective fertility preservation, for example sperm and oocyte or embryo storage for cancer patients, provided they show no symptoms of infection. It should be borne in mind that these patients may be immunocompromised, and shared decision-making involving the patient, oncologist and fertility specialist is key. Fertility preservation should only be carried out in patients who remain well during treatment, and provided sufficient resources are available to do this safely. Local arrangements will be needed to allow these procedures to take place.
Outpatient clinics and diagnostic work
As part of social distancing, it is reasonable to advise that all face-to-face work should pause, other than in emergency situations, and where delay would be detrimental to the prospects of patients. Where possible, clinics should facilitate telephone or video consultations. If patients are attending for face-to-face encounters, care should be taken to stagger appointment times to prevent large groups of people congregating in waiting areas. Group sessions and support group meetings should not go ahead while social distancing is in place. Staff who can work from home should be facilitated to do so where appropriate, by provision of remote access to electronic case records as confidentiality restrictions allow.
Patient support and communication
Clinics should be aware of the potential emotional impact of the disruption of treatment services on their patients, occurring on a backdrop of anxiety about the effects of the virus itself. Measures should be put in place to keep patients informed of changes to the service and the reasons for these. Patients are likely to have concerns about the effect of delay on their chances of success and eligibility for NHS funding. It is likely that the ongoing uncertainty about the length of delay will compound these worries. All members of the clinical team have a role to play in supporting patients, with a special emphasis on the role of trained counsellors. It is recommended that usual facilities for answering phone call queries be enhanced to account for increased demand around short notice changes in service provision. Clinic websites and apps have a role in keeping patients informed and allaying anxieties in a difficult time.
Issues concerning funding and eligibility
Clinics should establish liaison with commissioners of NHS services to clarify their position on funding of treatment cycles that are cancelled, and the eligibility of patients who reach age thresholds without receiving treatment, due to the coronavirus outbreak. Significant numbers are likely to be affected, and it is likely that individual Exceptional Funding requests will not be appropriate for the circumstances – we recommend that commissioners make timely decisions to guarantee treatment in the future for all currently eligible fertility patients negatively affected by the COVID-19 pandemic, to minimise distress and facilitate pathways once treatment resumes.
Centres should work to identify the minimum number of staff that are necessary to maintain urgent services such as fertility preservation for oncology patients. It is likely in NHS settings that a large proportion of medical and nursing staff will need to be redeployed to other areas, however measures should be taken to try to ensure that staff with the requisite skills and training to deliver urgent treatments are available at all times. If sufficient staff are not available due to illness, then centres should seek support through their reciprocal support agreements with other centres or networks.
Sufficient scientific staff should be in place to maintain and ensure the ongoing safety of gamete and embryo storage banks. To guard against the risk posed by significant numbers of scientific staff becoming ill and forced to self-isolate, centres should ensure that sufficient scientific staff are available and are cross-trained to deliver all key tasks including ongoing quality control and maintenance.
Appropriate levels of staffing should be determined by the person responsible, taking advice from nursing, medical and scientific professional leads within the centre. It is incumbent upon public relations (PR) to ensure that services are reduced in keeping with available levels.
Where assisted conception centres undertake diagnostic activities, such as semen analysis or post-vasectomy testing and these involve attendance at the clinic, these should be suspended in order to minimise social contact.
Where diagnostic services are part of NHS pathology (or other) departments, the above also applies and staff may be asked to redeploy during the epidemic.
Whilst every effort must be made to reduce services over coming weeks and months, it is necessary to think forwards towards a resumption of services. Maintaining contact with patients whose treatment has been disrupted or deferred is important, and consideration should be given to prioritisation when services are able to recommence. The timing of this will be dependent on ongoing Government advice, resumption of NHS normal working practices as well as centres' own staffing and other resources.
The BFS and ARCS continue to monitor the ongoing pandemic and advice from national authorities. Further guidance will follow as appropriate, with the ultimate aim of resuming normal services as soon as possible.