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Author Topic: Eshre guidelines maintaining safe fertility services during second spike COVID  (Read 645 times)
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Published 20 October 2020

New guidance from ESHRE for maintaining safe fertility services during a dramatic spike in COVID-19 case numbers has realigned mitigation steps according to local levels of infection.

As countries throughout the world face up to a second wave of COVID-19 infections, ESHRE and others have upgraded safety guidelines for fertility clinics. ESHRE has reaffirmed its guidance from April on the reopening of clinics after lockdowns (‘phase 2’ of the pandemic), but has now in this latest phase added two further measures as complementary to that April guidance: more testing in addition to the triage questionnaires; and greater information to patients on COVID-19 and its prevention before and during pregnancy.(1)

The new guidance also advises that mitigation measures should be in place depending on the level of infection in a region. Thus, a first core step in this latest guidance is to recognise the current epidemiological status of the pandemic and to assess its likely impact on internal resources (such as staff and equipment) and on patients. The second step is to plan mitigation measures according to that assessment to reduce those risks. A local notification rate of 20 to 60 cases per 100,000 population (‘moderate impact’) might require no further measures than those already applied routinely. However, an area of ‘major’ (60-120 cases per 100,000) or ‘critical’ (>120 cases per 100,000) would require more intensive measures – such as more routine testing of patients and staff, remote consultations, no accompanying persons, routine use of PPE, and even a freeze-all transfer policy. The measures relative to the case notification rate are set out in clear diagrammatic form in the ESHRE guidance.

The guidance was made public just a few days after the ESHRE COVID-19 working group published its review of resuming fertility services with mitigation measures after the initial flare of the pandemic.(2) The paper describes the measures needed to restart safe routine treatments in fertility clinics and the rationale behind their application. The review (published as an ‘opinion’) covers patient selection and informed consent, staff and patient triage and testing, the modification of ART services, treatment planning and a code of conduct. The code of conduct, as set out in ESHRE’s April guidance on the second phase of the pandemic, remains an important component of this latest guidance on the third phase.

The ASRM, though without the same infection spikes in the USA as seen in Europe, has also updated its COVID-19 recommendations to reaffirm the ‘judicious’ delivery of reproductive care within a framework of careful preventive measures.(3) With COVID-19 case numbers still running high in the USA, the ASRM describes these measures as ‘critical in managing this ongoing pandemic’.

The worry for clinics back in Europe must be whether this second wave of infection becomes so critical in some countries that some centres might have to close once again. However, it now seems clear that the guidance on the resumption of routine treatments provided by ESHRE, the ASRM and other authorities has offered effective protocols for the safe provision of service. The paper from the ESHRE COVID-19 working group just published provides strong point-by-point evidence of that.(2) And it's on this basis that the UK’s HFEA, for example, on 13 October reassuringly reported that with such professional guidelines in place ‘a new national closure of fertility clinics should not be necessary’. However, as ESHRE’s latest guidance notes, the HFEA also recognises that staff sickness or patient restrictions may yet force some clinics to close. It’s likely that some countries may also requisition hospital beds for intensive care support.

Meanwhile, patients and staff may be further reassured by results from a case report from Spain in which two asymptomatic oocyte donors tested positive for SARS-CoV-2 infection before egg collection.(4) The eggs were subsequently donated for research for the presence of viral RNA. However, total RNA amplification from single cells of their vitrified-warmed oocytes failed to detect the presence of any viral RNA of SARS-CoV-2 in the cells. The authors thus concluded: ‘Our report suggests that vertical transmission in these women may not occur through their oocytes during treatment, and that handling of this material in the clinical embryology laboratory may not constitute a hazard for healthcare professionals.’

However, a meta-analysis just published in Nature Communications of 176 published cases of SARS-CoV-2 infections in neonates has found that the majority of them (around 70%) occurred postnatally, although vertical transmission ‘may be possible’ in around 30% of the cases, either intrapartum or congenital.(6) Some 9% of these latter cases were actually confirmed as vertical infections. Just over half the infected neonates went on to develop COVID-19, while the rest were asymptomatic. One of the investigators, Daniele De Luca from the Antoine Béclère hospital in Paris, said that it was important for doctors to be aware that neonates can be born with the virus or contract it while in hospital. ‘At the beginning of the pandemic, some argued that this would never touch babies,’ he reported. ‘It’s rare, but it does exist.’ Breastfeeding seemed not associated with SARS-CoV-2 infections, suggesting that viral transmission through the milk, if any, ‘should be rare’.

Further details on COVID-19 and pregnancy, including updates from ongoing registry studies, continue to be provided in detail by the UK’s RCOG.(5)
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The COVID Vaccine: A Shot in the Arm for Fertility Treatment?
8 February 2021 - by Dr Ëlo Luik
The rollout of COVID vaccination programmes has brought with it a renewed hope of a return to normality but has also raised questions about the impact of vaccination on fertility treatment and pregnancy.

To help explain and clarify the advice to fertility patients and clinicians, and to fight misinformation spreading online, the Progress Educational Trust (PET) – the charity that publishes BioNew – held an online event.

'The COVID-19 Vaccine: A Shot in the Arm for Fertility Treatment?' was chaired by PET's director Sarah Norcross, and featured speakers outlining the approaches taken by UK, EU and US bodies.

Professor Jason Kasraie, chair of the Association of Reproductive and Clinical Scientists (ARCS), gave the first presentation – an overview of the UK guidance issued by ARCS and the British Fertility Society (BFS). He emphasised that there is no known risk in giving non-live vaccines to pregnant women or those looking to conceive.

ARCS and BFS say there is no need to avoid pregnancy after vaccination, and women who would benefit from the vaccine should receive it without compromising their planned fertility treatment. However, as with any medical treatment, patients should be involved in the decisionmaking process. Pointing out the prevalence of fearmongering misinformation online, Professor Kasraie stressed the importance of being careful about how risk is communicated, when there is currently no cause for fear.

The next speaker, Dr Anna Veiga, coordinator of the European Society of Human Reproduction and Embryology (ESHRE)'s COVID-19 Working Group, explained that ESHRE's relatively cautious position relates to an absence of concrete evidence.

ESHRE has decided not to offer a universal recommendation on whether or not men and women attempting assisted conception should get vaccinated before starting treatment, and instead emphasises the importance of weighing up the factors that are relevant to each individual patient. ESHRE recommends postponing the start of fertility treatment for at least a few days after the vaccine, to allow the immune response to settle.

Regarding vaccination and pregnancy, ESHRE suggests that pregnant women should not be vaccinated unless they are at particularly high risk. ESHRE also suggests that if a woman becomes pregnant after receiving the first vaccine dose then, then – unless the woman is at particularly high risk – the second dose should be delayed until the pregnancy is over. There is no advice to avoid pregnancy after vaccination.

Despite this cautious approach towards the vaccine, Dr Veiga noted that pregnant women have been shown to be at higher risk of developing severe COVID-19 compared to non-pregnant women. Women may therefore still decide to go ahead with vaccination, since the benefits of protection from COVID-19 might outweigh any theoretical risks from, vaccination.

Dr Sigal Klipstein, member of the American Society of Reproductive Medicine (ASRM)'s COVID-19 Task Force, explained that the ASRM's more permissive advice is based on assessing the known and very real risks of COVID-19 alongside the largely theoretical risks of the vaccine. As such, the ASRM recommends vaccination to everyone who can access the vaccine – whether before or during pregnancy – on the grounds that the benefits outweigh the risks.

To emphasise this point, Dr Klipstein gave the example of Israel's decision to make pregnant women a priority group for vaccination, due to their increased risk of developing severe COVID-19. Dr Klipstein further emphasised the important role of fertility specialists in promoting vaccination to their patients, their communities and the public, so as to counter worrying trends of vaccine hesitancy.

During the event, attendees were polled on whether they thought a consensus was needed between all relevant professional bodies on the COVID vaccine and fertility treatment. A clear majority (77 percent) voted yes, prompting Norcross to ask the panel if there was any hope of a consensus being worked out. All three speakers agreed that a uniform message would help avoid confusion and vaccine hesitancy, but that it would be difficult to achieve a consensus, due to each national body's need to follow the formal position of their country's health authorities. The speakers did, however, note that there was significant agreement on key points.

While most of the discussion focused on vaccination of women and the impact on pregnancy, there was an audience question about the impact vaccination might have on sperm quality. The panel agreed that there is no suggestion of risk to the quality of sperm, but that it might be beneficial for men to leave some time between vaccination and fertility treatment, simply to avoid any temporary side effects of the vaccine (such as a fever) having an effect on sperm production. However, it remains prudent for men to get vaccinated before a planned conception, not least so that they avoid the risk of transmitting COVID-19 to the pregnant woman.

Several audience questions addressed the lack of evidence available on the impact of the vaccine. The panel agreed that while there is currently little evidence on the impact of the vaccines on IVF treatment, gamete donation or the health of newborns, there is new information coming in constantly and at unprecedented speeds. Studies of long-term effects will by their nature take time, but there is reassurance to be drawn from studies undertaken on other non-live vaccines.

Dr Klipstein warned against the temptation of an overabundance of caution in the absence of data, as this could end up forcing women into an impossible scenario of weighing up the risk posed by COVID-19 to their own health with any theoretical risks to their baby from the vaccine. Professor Kasraie observed that IVF patients are known to be especially anxious during the pregnancy, so placing them in a position where they have to shield throughout the nine months of pregnancy – for fear of catching COVID-19 – could exacerbate their isolation and anxiety.

Overall, the event showed that despite some differences in the advice given by UK, EU and US bodies, there is significant agreement on the important role of vaccination in protecting the health of fertility patients and professionals alike. Evidence of the harm that can be caused by COVID-19 during pregnancy is clear, known and real. Evidence of harm that can be caused by COVID vaccines is at best theoretical and unsupported by evidence. Certain precautions may be taken in the absence of data, but it is important to ensure that such precautions are not taken to be an indication that there is a known risk.

PET is grateful to the Edwards and Steptoe Research Trust Fund, the British Fertility Society, the Bristol Fertility Clinic and CooperSurgical for supporting this event.
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1 February 2021 - by Jen Willows
A new research paper warns that COVID-19 can affect men's sperm, but it may not be that simple.

Researchers from the Justus-Liebig University in Giessen, Germany published a study in Reproduction, showing that the sperm of men who had been diagnosed with COVID-19 showed increased sperm cell death, inflammation and oxidative stress compared to the sperm of men who had not had the virus.

'These effects on sperm cells are associated with lower sperm quality and reduced fertility potential' said lead researcher Behzad Hajizadeh Maleki. 'Although these effects tended to improve over time, they remained significantly and abnormally higher in the COVID-19 patients, and the magnitude of these changes were also related to disease severity.'

The research looked at sperm samples from 84 men who previously had COVID-19 and 105 who had not. Samples were collected every ten days for 60 days, and were screened for a number of indicators of sperm quality. On average, the samples from men who had been ill with COVID-19 had reduced sperm concentration and mobility, and had four times more misshapen sperm.

It is known that the cells in the testes have the ACE2 receptor, which the SARS-CoV-2 virus uses to infect cells. This issue was discussed in December at the annual conference of the Progress Educational Trust (PET) – the charity that publishes BioNews (see BioNews 1077). However, it is unknown if this is related to the effect on sperm.

'Being ill from any virus such as flu can temporarily drop your sperm count (sometimes to zero) for a few weeks or months. This makes it difficult to work out how much of the reductions observed in this study were specific to COVID-19 rather than just from being ill' said Dr Channa Jayasena, a reproductive endocrinology and andrology specialist from Imperial College London, who was not involved in the study.

Professor Allan Pacey who spoke at the PET conference pointed out that 'sperm production takes just under three months (roughly) to be completed from start to finish... It would have been more useful to see whether there was a difference at 90 days between the two groups.'

He also added that the men with COVID-19 had been hospitalised and would have been given a number of medications, which the control group were not.
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