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Update on COVID-19: A conversation with members of the ASRM COVID-19 Task Force

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TRANSCRIPT

0:03

Hello to everyone. I am Sarah Ramaiah Curriculum Designer at ASRM. Thank you for accepting this invitation and welcome to the ASRM webinar “ASRM Patient Management and Clinical Recommendations During the Covid-19 Pandemic.” Joining us are panelists Dr. Catherine Rakowski, President of ASRM and Chair of the ASRM COVID-19 Task Force. 

0:33

Dr. Peter Schlegel, Immediate Past President of ASRM. Dr. Kevin Doody, Immediate Past President of SART, and moderating the Q&A session is Dr. Ricardo Azziz, Chief Executive Officer of ASRM. Before we begin, please note all attendees will be muted except the presenters. Time at the end of the presentation will be reserved for questions.

0:58

Please type your questions in the question chat window at the bottom of your gray toolbar at any time. All questions will be moderated through this window. We will read as many selected questions as possible to the presenters during the allotted question and answer time. A recording of this webinar will be archived on the ASRM website in the coming weeks. Please watch your email for notification. To introduce our speakers today I will turn this webinar over to Dr. Catherine Racowsky.

1:32

Well, thank you very much, Sarah. It is a great pleasure to be here and as Sarah said we have myself as the first speaker and then Dr. Schlegel followed by Dr. Doody. So, I'd first like to very much welcome everybody to this webinar. This is the first. I don't have any financial disclosures of any sort. So, this webinar is really the first of what we hope to be many for our society. 

2:01

This is a particularly poignant webinar considering the unexpected challenges that we're all facing as professionals and as society members. It's a critical time in the world and we as a community of professionals really need to come together, stay together. As we all know a community is really is only as strong as its individual members are, so I again very much welcome everybody. 

2:31

I hope that by holding a webinar such as this as we all feel a little bit less isolated and more connected during these substantially challenging times. So, as I mentioned I have with me today, Dr. Schlegel. So, what I will be doing is first, I will be discussing the COVID ASRM Task Force recommendations. And then following this Dr. Schlegel will talk and he will be talking particularly about the New York perspective

3:01

and giving a sort of a more global perspective not global in the global sense, but nationally of the extent of this viral pandemic. And then following Dr. Schlegel, Dr. Kevin Doody will be talking with us. Dr. Kevin Doody will be talking about SART messaging with respect to messaging both to providers and patients. So, and then following that we're going to have a question answer session. 

3:31

This will be moderated by our CEO Dr. Ricardo Azziz and then finally hopefully we'll have a little bit of time to reflect on the way forward. So, let's proceed to talking a little bit about the Task Force itself. So, before I start discussing this, I really would like to acknowledge and thank every member of the Task Force.

3:52

There's been tremendous amount of commitment to trying to write a guidance document with recommendations that we really feel is the right thing to do and to help guide our members of our society during this terrible time. This task force is comprised of experts from the ASRM and from our affiliate societies and groups. We also have a few other members from the outside that have been very helpful in drawing up these guidelines. We've really invested a significant effort in this endeavor in generating the recommendations and guidelines

4:31

to our reproductive health practitioners and that patients during this unprecedented time. We try to base our recommendations on the best and most current data available. We all know that the times are very fluid. Things are changing almost day-to-day and therefore as you know, we're going to be updating our guidance document every two weeks at the absolute least. So, we've already published two documents. We've published the

5:01

recommendations which came out on March the 17th and then a true to our word, we said we'd published an update within two weeks, and we did so on March the 30th. So hopefully you've all seen these documents there on the ASRM website. If you've not seen them. The one on the left is the patient management and clinical recommendations during the coronavirus and the one on the right is our first update number one, which is you’ll note

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is current from March the 30th through April the 13th. And we'll be updating this again, update number two on or prior to April the 13th. So, every two weeks we're planning on, as I mentioned, on doing an update of these recommendations. So, what are the underpinnings of the recommendations? We really spent a huge amount of time really thinking about what really is going to guide the recommendations of our recommendations.

6:01

And the very first thing that really came to mind, I think we'd all agree, is guarding the health and the safety of our patients and our staff. That should be the number one priority. We felt, number two, we felt we needed to be socially responsible and consider conserving critically needed healthcare resources. We all know what's going on in New York and well hear much more about this from Dr. Schlegel. 

6:31

Things are really bad there and this is, as the governor of New York Andrew Cuomo said, in some respects New York is the canary in the coal mine and unfortunately, it's quite likely that what's happening in New York today may well happen in other states in the nation going forward. We already see hot spots such as in Florida and Louisiana. So then in addition to guarding the health and safety of our patients and our staff and helping to conserve critically needed healthcare resources,

6:58

we also felt that our guidance should be guided by recognizing our social and community responsibility. In order this for all these three things to come together,

7:11

and only if they are together combined, can we really contribute to what we refer to as flattening the curve. And we all have seen this graph and I’ll just show it here very quickly. Each one of us counts in this. We've heard this from the epidemiologists. We've heard it from Dr.  Fauci. He has talked at length about this on the White House podcasts and updates daily. You can see that the red curve without protective measures, the number of cases gets much higher than it does with the blue curve where we are implementing protective measures. And you can see the hash,

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the dotted line here is the line  above which we start losing the ability to provide appropriate care for patients because the healthcare system reaches capacity. And so this flattening of the curve, as we now know and we've been told us over and over again by so many different people, can only really be achieved if we all do social isolating, that we shelter in place and we stay within ourselves, within our families and don't go outside, because that's the only way that we're going to be able to control the transmission rate of this dreadful disease. I want to acknowledge here David Holtgrave,

8:31

at the University of Alabama who prepared this slide. So, what about the key recommendations, the original task force recommendation guidance, which as I say was published on March 17th. So, the first recommendation was that we really felt, and we feel today that new treatment cycles should be suspended. We are referring here, of course, to ovulation induction, IUI, and IVF as well. We recommend secondly, strongly consider canceling all transfers. Thirdly,

9:06

take care of in cycle patients and care for those requiring urgent stimulation for fertility preservation. Fourthly, we recommend suspending elective surgeries and non-urgent diagnostic procedures.

9:20

And fifthly, as I mentioned, minimize in person contact and increase the use of telehealth. I think we all would agree that we're spending a lot more time on all these electronic communication media such as zoom and all the other, Skype and all the rest of it, and certainly only telemedicine and telehealth should be encouraged in these times.

9:40

So, the detailed recommendations are laid down in this guidance document under the sections risk mitigation and social distancing, controlling patient travel. So, each one of them is playing their part in controlling the rate of transmission.

10:00

We also have a section on practice management, management of the embryology and andrology laboratories, and then finally the support of health and well-being of patients and staff. This last one is important. And we aren't just referring here to trying to help the health of the patients and staff, but we're talking physical health, and mental health as well. And I'm sure that Dr. Schlegel is going to be telling us more about the stress, the emotional stress going on in New York. It's not just in New York, however, it's everybody feeling enormous stress from this

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by virtue of the unforeseen challenges that we're all facing that came up so quickly out of nowhere.

10:50

So, the update that we published on March the 30th, we felt needed clarification. I would like here to acknowledge a letter that was sent to us by the Fertility Practitioners Alliance. This is a group of about 40 practitioners who wrote a letter in response to our original guidance document and in fairness,

11:14

there were many things we didn't clarify very well in our first document. We tried in this update to really address those. Certainly, there was no intention whatsoever not to write a clear document and there was a lot to write in a very short time. But first and foremost, and very importantly, we'll all agree that infertility is a disease. There's no question about that. Infertility was defined as the disease several years ago. The WHO has endorsed that, and I think all of us in the field would agree

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that it is a disease. Secondly, I think we'd all agree that infertility treatment is not elective. No one has chosen to have infertility and the treatment itself should not be considered ‘elective’ however elective in this context really, and this was reflected in the update that we wrote and published on March the 30th, elective in this context

12:15

refers generally to a surgery that can be delayed or is considered it to be non-urgent. The American College of Surgeons defines it in this way. And the final important point to clarify is the issue of urgent versus non urgent procedures.

12:35

So I'm sure if you read our guidance document and read the update at the moment, we're not distinguishing between particular patient categories that might be considered much more urgent than others, for example, diminished ovarian reserve and patients that are on the older side. As things evolve, it is quite probable that we will have to and feel it is important to revise the document so that we can take into consideration what might be considered more urgent cases of patients going through IVF.

13:11

But as things stand now, we still stand by all patients being considered together as being those that should not have new treatments, just again, because of the social issues here and really trying as a community and as professionals. Our society is 8,000 people. It's not a small society and each one of us has a responsibility to really flatten the curve and control the transmission rate of this dreadful disease.

13:43

So, the details of the recommendations and of the update really reiterated what we said in our first document. We continue to support the recommendations of March the 17th, and I've just gone through those five recommendations with you. We continue to be committed absolutely to the return of patient care, as soon as we possibly can do that. We continue to emphasize the importance of the safe storage of reproductive tissues. Obviously, this is of paramount importance.

14:11

We don’t need to go into the ins and outs of that. We recommend leveraging telehealth/telemedicine to try to control the number of people that must walk around. There's a lot of ways that we can undertake telehealth now. And then finally as I mentioned, continuing to emphasize enhanced emotional/psychological support for patients and staff that are really needed in these unprecedented times. We have on our task force the chair of the mental health professional group and Anne Malavé.

14:43

She's been fantastic in helping advisors in how best to do this. And I know that that group is putting together much more coherent and extensive documents than we mentioned in our guidance document.

14:58

So, the principles that underlie our task force recommendations, I've touched on them, but I really wanted to bring them to together in a much more cohesive form. So, the number one principle is that the recommendations are based on public health and CDC recommendations for suppression of viral transmission. This virus has a transmission rate is much more contagious we believe than any other virus that has occurred so far to date.

15:27

So, we really have this public responsibility to do this which is why we're recommending that patients should not undergo new treatments now when everything is still very much under out of control in our country. The recommendations therefore aim at decreasing the risk of the transmission to our patients, staff, and physicians, and the population at large as the pandemic continues. This is important and we will stand by this. We're trying to do what we feel is best for society, for our society, the ASRM and Society at large. So, as the pandemic continues the task force recognizes that there will be a need to update these recommendations to include how to provide safe patient care in the era of COVID-19. It's very unlikely that COVID-19 is going to go away for many months. We all recognize all the issues involved in terms of economics as well as the stresses and strains

16:27

on the patient's themselves in wanting to have treatment for their infertility. And so, it's almost certain that we'll be opening our practices at some point when COVID-19 is still a virus and still transmitting from human to human. And so, we're staying on top of this. We're hoping that very much in the relatively near future,

16:47

although we have no idea when, we're going to be able to loosen the recommendations from the ASRM Task Force, so that patients can start new treatment cycles again. With that just a couple of closing remarks. So, the impact on individual health lives and livelihoods is both humbling and terrifying. We all know this and we're really feeling it, each one of us. But I'm sure not nearly to the orders of magnitude as what's going on in New York today. Dr. Schlegel will be picking up the baton in the moment and talking about that.

17:26

The ASRM efforts are really focused on how best to help quicken resolution of this pandemic so that we can get back to serving our patients as quickly and as safely as possible. In the few days since we announced our offering of certificate courses free of charge, I'm really delighted to say that more than 650 people have signed up to take advantage of this offer.

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We felt this was the least we could do as a society to help people while they're not necessarily going to work. They have time to improve their knowledge, and just to give them a perk as members of our society. Our Government Affairs team has been busy discussing what our community needs with policymakers. Dr. Doody is going to be talking more about this. I think with respect to the SART messaging immediately after Dr.

18:19

Schlegel has spoken. I will just say the obvious and I say this from my heart, I think people who know me well know that I don't say things that I don't mean. We are really all in this together and I sincerely believe that we will get to the other side. But we've got to stick together on this. We're so much stronger together than we are separately, and I really urge those of you who have questioned whether we are doing the right thing by stopping the new treatment of patients. I really would urge you just to ask yourselves. Are you doing the right thing by continue to see patients as we are here today?

18:57

still on the upward curve of this dreadful virus. We have got to each do our part to try to control this. So, thank you so much. I will now pass things over to Dr. Schlegel. Dr. Schlegel as you know, is the immediate past president of ASRM. I mentioned he is going to be talking with us about the situation in New York and what's going on nationally.

19:32

Thanks Catherine. Let me just back up a little bit in terms of the information we're going to discuss and go back to some basics and talk a little more about what occurs when this disease comes through a community. Can we move to the next slide, please?

19:52

I have no Financial disclosures.

20:10

So, this disease is caused by SARS-CoV-2, a novel coronavirus.

20:16

It is an RNA virus with a lipid envelope and that's very important to how we prevent this disease from transmitting from person-to-person. Infection with SARS-CoV-2 to virus causes the disease of COVID-19, just to define what COVID-19 is. It is an illness that typically presents with fever cough sore throat, a distinctive loss of taste and smell as well as shortness of breath. Although a wide variety of atypical presentations can occur as well. And certainly, when the virus starts to affect a community we are often as healthcare workers tricked by these patients who come in with for example, predominant diarrhea and no other symptoms.

21:08

Similarly, if you look at elderly patient’s half of them, do not even develop a fever even with advanced disease.

21:18

As Catherine alluded to, this is a very insidious disease because the virus has an incubation period of 5 to 10 days and patients are thought to be most able to transmit virus a couple of days before their symptoms develop. Even after symptoms develop, it may take another four to eleven days before patients develop disease

21:45

that is so severe that they require hospitalization. All adults can be affected even though children are relatively unaffected. If we look at the New York City Hospital admissions 38% of those admissions are occurring in individuals who are 18 to 44 years of age. So, this is affecting the young. One of the misstatements people often make is I'm young, I can't get it. You certainly can get it and you can be extremely ill, intubated

22:19

in the hospital with it. Interestingly, it appears to have a male predominance or predilection 56-62% of those affected are male. The risk of death does tend to be highest in the elderly and those with comorbidities. We're now starting to understand that more advanced disease a little more clearly. It often is associated with a micro-angiopathic thrombotic tendency.

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almost like a DIC but without a bleeding tendency and it's often associated with high D-dimers.

22:59

It is spread by droplets as well as by contact. Now, the virus typically dies on surfaces within 4-48 hours, but it's important to remember what occurs when you either speak, cough, or sneeze. So, the recommendation that people stay six feet apart is because droplets that come out just by speaking and the more loudly that you speak the farther the droplets go,

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but even by speaking droplets will go four and a half feet coughing at least six feet and sneezing can really contaminate an entire room. Because the virus has a lipid layer on its outside it can be easily destroyed with alcohol-based sterilizing agents as well as handwashing with soap for 20 seconds or more.

23:57

In most diseases, viral diseases particularly, you would like to avoid viral spread with containment. We lost the opportunity for containment in December. Now our best approach is our mitigation: limiting the ongoing spread that occurs of this virus, which again, is typically person-to-person. Social distancing, staying greater than 6 feet away,

24:25

staying at home, avoiding large groups are critical components of this social distancing and mitigation to limit the amount of spread of the disease. Covering your mouth when you cough, or a sneeze is critical. We found and have seen with now decreasing death rates over time that the earlier that you institute

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dramatic steps throughout the entire population such as what was done March 10th in Washington state, what was done in New York state in March 20th, and Michigan as well. These are critical steps. If you think about it, you have widespread infection throughout the community, even after you Institute these steps. It is going to take a minimum of 10 to 15 days before you see a decrease in disease

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propagation through the community. So, with these steps that were taken in Washington state on March 10th, you can see flattening of the curve in terms of the amount of disease that spreads. New York state is seeing a continued increase and in part that's because the greatest effect of mitigating spread occurred in the New York City areas and still there are other components of the state where the disease has

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continued to propagate. Again, exposure to symptoms to development of disease five to ten days, four to 11 days for severe disease, so mitigation effects take up to 15 to 20 days.

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Community-based spread is difficult to control without highly effective quarantine efforts. And if you look at the curves in terms of death rates, either in China or in Korea, they are the result is of dramatic and substantive steps that were taken in a relatively authoritarian areas where people were absolutely prevented from going outside and communicating or interacting with

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any other person.

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A good example is a second person who is infected in New York state. This was an individual who is in Westchester County about 20 miles outside of New York City. Over one weekend, he had over 1,000 contacts which then had to be quarantined and out of those 1,000 people a hundred and twenty were infected. 

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Current estimates from Iceland and a series of other studies suggest that 18-50 percent of the infections result in minimal or no symptoms are current modelers suggest that up to 33% of the New York City population are thought to have been infected and are probably potential asymptomatic carriers.

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These observations have substantial importance as we think about running a medical practice and bringing apparently healthy individuals in to interact with our other healthcare workers as well as other patients. It outlines just how risky that can be to your other patients.

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So, summarizing where we stand in New York state right now, and these data are from this afternoon, total number of cases 92,000.

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They now affect every County in New York state. 47,000 of those cases are in New York City alone and in New York City there have now been twenty-four hundred deaths. Just to remind you a week ago in New York City, there were 285 deaths. So that is almost a tenfold increase. Certainly, by tomorrow it will be a tenfold increase. Even at the most capable hospitals, hospitals which have some of the greatest resources of any Hospital in the country, we have seen that the morgues become overrun,

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you don't have enough time to get refrigerated trucks in time,

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funeral homes are refusing to accept bodies. This is dramatic and very sad for what we have in one of the most advanced healthcare systems in the world.

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So, the growth of disease really threatens to overwhelm our healthcare resources, those resources are available to manage the disease. For one New York hospital system which cares for about 22-24% of all New York City COVID positive patients, their baseline ICU capacity was about 400 beds with a total inpatient capacity of over. 3,200 beds.

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25-30% of the patients who are admitted to the hospital will end up in an ICU on a ventilator, often on a ventilator for 10-15 days. As of April 2nd, 2020, this institution that had 400 ICU beds has 487 COVID positive patients being ventilated in ICU beds. How did they do that?

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Well, they estimated that we're going to need 1,100 ICU beds. That means taking step down units, PACU areas, and every operating room that is not needed for an emergency procedure and converting operating rooms into 2-bed ICUs.

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Every operating room can become an ICU because it has an anesthesia machine that could be used as a ventilator with an additional ventilator is used for the second patient.

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It is also required conversion of an Ambulatory Surgery Center to ICU beds. That's provided another ICU series of a hundred ICU beds for that system. So, if you are in an Ambulatory Surgery Center, you say that my resources are not important for hospitals, the reality is your ventilator,

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your resources could be helpful as disease overwhelms a community. Converting an adjacent specialty hospital with ORs to ICU beds is also how this hospital has approached the 1100 bed capacity.

31:35

Now there are limitations and risk in disease management, which really are related to specific supply problems. One of the things we recognize to begin with is space was going to be a major problem, particularly space for creation of ICU beds.

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The next step that we saw in terms of a challenge was testing capability. Testing capability for the virus basically existed at about 50 tests per day and it's now been mobilized up to 3000 tests per day but that's required all kinds of new machines, new resources, and as you ramp up that quickly you find that you run out of things like reagents. You run out of nasal swabs.

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This ramp up in terms of healthcare activity is so dramatic and so rapid that we find on a regular basis, we are short of equipment. One of the first areas we were concerned about equipment shortages was in personal protective equipment, particularly n95 masks, but frankly even surgical masks. We now use a hundred thousand masks per day in the hospital setting.

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We're also risky in terms of our ability to have medical personnel to staff these areas as well as nursing personnel. This has really become an all-hands-on-deck type of situation. We've created pure pyramidal teams that work in the ICU.

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So, you have an experienced intensivist, the intensivist heads up the entire group. You have senior physicians working underneath him or her. And then you have teams of Junior attending physicians, residents, APPs who basically extend out your ICU capabilities. That's how you can manage all these ICU beds that again, were not present immediately in your system. The next area that we ran into supply problems was in ventilators. We have staff who stay up now all night so that they can manage to resource ventilators

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from China and get them here before we hit the peak of disease activity. What's going to be our next supply chain limitation? We don't know at this point. We think we're a step or two ahead. But frankly, we've thought that we were there before.

34:08

Cessation of elective surgical procedures really occurred for several reasons. One, we needed the PPE. We couldn't use all those gowns and masks for procedures that weren't urgent or emergency procedures. We also needed both the Ambulatory Surgery as well as the operating rooms ICUs and plus it limited our ability to use staff and deploy them to take care of COVID patients.

34:37

Stay at home also means cessation of non-urgent office visits. We now have the regular question: do we really want to bring a patient in for an office visit? What risks are we exposing them to by doing that? And is that worth the care that we're going to provide?

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Telemedicine is obviously become the predominant way that we provide care to most of our patients on an ongoing basis. We're fortunate that we were well-equipped to do telemedicine to begin with and it was part of our electronic medical system. But ramping that up has been critical.

35:19

Risk of disease transmission is critical when we think about our patients. There is a very high frequency of viral disease in the community that occurs before you recognize it. By the time you figure out that patients are infected, they've infected all your other patients and staff as well. These asymptomatic periods with viral infectivity are very concerning. Most of my colleagues who are health care workers who have become infected have gotten infected

35:48

caring for patients who had apparently non-COVID related disease like appendicitis or a kidney stone, but it turned out they were carrying the virus and transmitted that to healthcare workers. Similarly, some of our patients unfortunately, particularly younger patients, fail to heed restrictions on disease mitigation. We've had patients come in for fertility evaluation who are febrile having been exposed

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to known COVID carriers and thought that because they're young they couldn't either get the disease or transmit the disease and unfortunately have infected others.

36:30

Now what are the effects of COVID-19 on and during pregnancy? I've got to say that the overall data are quite limited. This survey that was just published this month by Dashraath in AJOG goes over a comparison of COVID-19 to SARS and MERS. Very few cases of pregnancy with SARS or MERS infections have been described. A few more with COVID-19. Clearly 55 patients do not allow us to adequately

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describe what the effects this virus is going to have on pregnancy or children. This small analysis did suggest miscarriage or stillbirth in two percent of cases, IUGR in 9%, preterm birth in 43%, and neonatal deaths in 2%. Now most of the women who are infected were in their third trimester. This is a lower than reported fetal complication, maternal

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complications than seen from SARS or MERS but those tended to be very severe diseases as well. There appears to be limited viral transmission to the fetus. But again, data are early. Interestingly, the detection of COVID disease during labor or immediately after labor has become so common in New York City that all laboring patients are now tested at the time of admission. I can tell you that this vasculitis

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which is seen with microangiopathic thrombosis occurs in five out of six placentas that have been examined so far. These are very preliminary data, but they suggest concern about having the infection when you're pregnant.

38:19

In summary, this disease has rapid dissemination throughout the population. New York City may have been further set up for that because of higher population density. If we look at areas like Queens, Brooklyn, and the Bronx, where there's even higher population density than some other regions of New York City, the propagation of disease has been worse. It clearly has a substantial risk of stressing our medical resources.

38:47

Continued fertility care in this kind of setting clearly carries risk. It carries risk of disease transmission to or amongst patients. It carries disease transmission to your health care workers that you employ in your clinics.

39:04

Risks of using PPE as well as ventilators and convertible medical resources, it could be of critical benefit for treatment of ill patients, is somewhat of an ethical concern

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if you're providing less than urgent or emergency care. The incompletely defined risks of COVID to the pregnant women are also of concern. That concludes my comments about where we stand in New York City, and I'm now going to turn the presentation over to Dr. Doody. Thank you, Peter. That was excellent.

39:53

So, I do have a disclosure in that my wife and I are owners of CARE Fertility in Dallas/Fort Worth and this is a medical practice as well as an Ambulatory Surgical Center and laboratory that has been greatly impacted by COVID-19 as have many of others we know. So, my practice is not unique. It's one of 370 SART member practices that have been profoundly

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impacted both by the virus, its effects, and the responses of local governments, and responses of the ASRM COVID-19 Task Force. I think it's important for everyone to know that SART was represented on the COVID-19 Task Force and stands behind the guidance that have been recommended. In addition.

40:50

I think what I want to point out is that SART over the last two weeks has really mobilized its resources for both patients and members to navigate the evolving changes that we've needed to handle the crisis. We can see front and center on SART’s homepage that there is an alert for patients. The purpose is really to help our patients in understanding the task force guidance and then on the bottom what we see are the links to the ASRM information that is helpful as well, including what Catherine mentioned as far as the no charge for ASRM member embryologists, andrologists and nurses to complete their certificate courses.

41:46

So, I'd like to start with the messaging that we've done for patients.

41:52

And this is very important because patients really have a unique perspective in how this is being handled. And they have a lot of questions. I'm not I'm not saying that these questions should necessarily be linked to on your own websites or plagiarized by your nurses, but they can be used by physicians to help answer these frequently asked questions, but I think it they can be useful in guiding an appropriate responses. As physicians.

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we tend to think about things from a medical aspect and SART reached out to our partners in RESOLVE and the mental health professional group to help us construct answers that consider the emotional burdens that our patients are feeling. And just as an example, the answer to this question - will postponing my care affect my ability to have a child? As a physician how  might I answer that? Well, no, there's no evidence that within one or two months a delay of treatment is really going to have a big impact but it's important to recognize that the patients really do have an emotional component to it. They've gone through tremendous grief by the time they've gotten to the place where they're doing an IVF cycle.

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And all of this is daunting. So, you might take a chance to look at the answers.

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The other question that many of our patients have asked especially when we're counseling them about whether they should proceed with an embryo transfer that they've been in cycle with is, should I get pregnant. Or if I'm subfertile and not necessarily sterile, should I be using contraception during this time?

43:47

And you know, we've come out with a very clear statement that we’re not saying that women shouldn't get pregnant. We're also not saying that there's no risk. The risk of acquiring the coronavirus in the first trimester, really as dr. Schlegel referred to were, they’re not known and they're not going to be known for some time. We do know that severe illness can lead to pregnancy complications. If patients were already pregnant, they should be taking all the precautions to reduce their exposure. Obviously social distancing is the biggest one among them.

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We also listed for patients some tips and some resources for them that that I think are quite useful. The resources that we link to are RESOLVE is a very active online support community.

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We've also linked to the ASRM’s mental health professional group, and they have further links, but just some ideas for our patients and perhaps they're good for us too. Limit your use of social media and other sources of news. Use some relaxation or mindfulness applications to reduce anxiety. Distract yourself with some non-COVID related topics. Stay in touch with your support network, etc.

45:20

And then finally that was the messaging that we've done for our patients,  for our professionals under the professionals and provider tab, we have a COVID-19 resource link. This includes a message to our members, some tips regarding the safety of gametes and embryos, and an account of one of our own, a reproductive endocrinologist

45:50

At the epicenter of initial exposures in New York. So that message to membership is quite long. I'm not going to go through this. I want to allow some time for questions and answers, but I'd encourage everyone to take the time to read it.

46:10

And again, I'd encourage the embryologists to look at what we've come out with in terms of some tips for maintaining the safety of gametes and embryos. Probably not going to be a problem but recognize that the suppliers of liquid nitrogen are also typically the suppliers of medical gases including oxygen, and they may be forced to prioritize in the future. It's important to think about staggering your

46:38

embryology staff whether that's green team, blue team or some other method, so that any so that you're not at risk of not having people able to take care of your tanks, etc. And then finally I encourage everyone to read this story from one of our own, Dr. Harry Lieman from New York. He talks about being in the first containment zone, seeing his friends and colleagues.

47:08

become sick and having really his whole life up ended. It's a very powerful story.

47:17

I will say also that our message to members will be updated periodically. We expect a new one to come out tomorrow. So, if you've already read the one we have, know that another one will be out tomorrow or perhaps latest on Monday. And then finally just to tout another link that we have, which is the relief package that I think going to be so important for a lot of our practices that are small businesses.

47:45

So, there will be a webinar tomorrow that the ASRM is putting on that will discuss this and bring in some experts to give a lot more detail. But thank you. I'll be turning it over for questions and answers.

48:03

The floor is now open for questions. Dr. Ricardo Azziz will be moderating the session.

48:13

Thank you very much Drs. Doody, Racowski and Schlegel. That was as always fascinating. There are several questions that our audience has sent us, and more are popping in so I'm going to start out trying to merge some of the questions. The first one really has to do with the impact of flattening the curve. If flattening the curve does or does not extend the period at which we are in a pandemic

48:43

and that of course will have implications for our recommendations as well as a treatment of our patients. Could one of you, maybe Peter speak to the impact of the flattening the curve on the duration of pandemic.

49:01

So, Catherine showed the outline of flattening the curve and the concept primarily of flattening curve is at you just are trying not to overwhelm your health care resources. I talked about one of the most capable hospitals in the country barely being able to deal with this crisis 11-12 days as a peak after severe restrictions were put into place. All non-essential businesses were closed.

49:31

Everyone was ordered to stay at home. No one travels to work. No one is on the subways. So basically, if you do that, you're dealing with the peak as your greatest concern.

49:45

If you have a lower peak, you're going to have a lower tail after that. How long the tail continues really depends on the disease that persists, the amount of viral contamination in the population and when you go ahead and free people up to get back to normal activities and interaction. Because even a relatively small amount of viral contamination in the population spreads extremely quickly. So, I don't think we have perfect information on whether you're going to have a long tail because you flattened a peak. It appears to be a similar period. You just don't overwhelm your health care resources.

50:31

Thank you, if that's the case and maybe the group would like to respond. There are several questions about if that is the case and we expect that the pandemic will be with us for certainly weeks, if not months - what is the threshold at which the recommendations may begin to change? How do we begin to address long-term the care of infertility patients?

51:00

It's interesting as we look at models and you know, the modeling people are kind of math nerds who sit and put together a whole series of inputs in terms of how quickly disease is spreading, how much disease is present within the population, and use that to predict out where we go.

51:24

So obviously, you've got to be at a low enough disease prevalence to get people back to activity and that includes routine care visits. It includes having patients come in and starting treatments like fertility treatments. If I could just weigh in a little bit as well Peter, if I may so the ASRM is very aware of this issue of when we can return to work and when we can start treating patients again. Our society is working very closely with other organizations

51:58

and of course, looking and watching the CDC guidelines on a day-to-day basis. We're not siloed in our guidance of staying at home. This is becoming the norm as Peter says in New York. It has been the norm now for I think probably well over a week. They've not being allowed to leave their homes. And I believe I'm right in saying now that it's well over 50% of the states that this is the case. Some states it's not but nevertheless the whole idea here is just to get back

52:31

to this business of flattening the curve and how long this might go on. I think it probably is fair to say from the reading that I've done, that flatten the Curve will extend the duration of the disease being in the public domain. But again, is it worth losing lives?

52:48

Because you're overtaxing the hospital systems in order to allow people to continue to do medical procedures or should we all be thinking about what is best for society. I hate to keep harping on this, but I have a very opinion about this. I think we should be doing what's right for society. Yes, but I'd like to echo that, but I think it's important to bring out that the task force is committed to revisiting this every two weeks. And as things change you can take all the models that are out there, and we really don't know, it may be that it may be a localized when it returns

53:31

to function because places like New York, that have a higher peak they may take longer to get back to where it's not going to overwhelm their system. So, I think that's the important point is that we're looking at that. Yeah. I think that's a very important point and valid point, Kevin. We know that the penetrance of the disease now is very different from one state to another. The whole question is how is that going to look in two weeks or a months’ time?

54:01

Are these states that now have very low penetrance? Are they going to continue to have very low penetrance or are they going to be in the situation that New York is now in, that Louisiana is threatening to be in, Florida has been threatening to be in. And one of  the biggest problems here is we simply don't know. We do not have experience with managing something of this enormity.

54:26

Very good. Thank you. There is a question, a couple of different questions, that ask the same in a different way. So, there are still practices who remain open door, there are larger practices who are still seeing patients and the question then becomes from the attendees:

54:47

Why should they then follow guidance if other practices are not doing so? And is that issue something that SART is going to address or not? I'll take that one. So, some folks may want to engage in risky behavior, but it doesn't mean that we all should. So, there is no safe way. There's no way to guarantee complete safety. Right? So, hand washing is not going to do it. Hand sanitizer at the front's not going to do it. Taking people's temperatures not going to do it.

55:25                                                                                           

This is a virus as Peter mentioned, people breathe it out before they’re symptomatic and other people can breathe it in, and it can be in a closed air environment. It can be there for 30 minutes or even longer. So, you can't make it safe. Why we should do it because we want to protect our patients. We want to protect our staff. We want to protect our families. And that's why we should do it.

55:56

And you're right there are some there are some clinics that don't appear to be viewing it with as much concern as a lot of us do. Will they be kicked out of SART? What I would say is this is not a guideline that has gone through the normal ASRM process. And so yes SART members do have to abide by ASRM guidelines, SART

56:26

Guidelines, and at the present time we're not we're not looking at kicking people out. Not saying that this is something that they should be doing by any means. Thank you. There are several questions about specifics in management. For example, we discussed converting rooms, Peter you discussed converting the rooms to ICU.

56:55

Is there a way that Ambulatory centers and other similar facilities at many of our medical practices have, can they be used for ICUs in a community if their local hospitals become overwhelmed? Yes. Absolutely, they can. So, the Ambulatory Surgery Center that I was referring to is a separate 12 operating room plus endoscopy suites,

57:26

I think 20 endoscopy suites. And if you take that and you take the recovery areas for that modest-sized Ambulatory Surgery Center, it can be completely converted to an ICU-type setting. Now the challenge with that is you need the resources of a hospital in terms of ventilators, ICU materials, medications that you wouldn't routinely have there to support it.

57:50

So, it's possible to do but it would require a very close collaboration with an inpatient hospital setting. But again, the Ambulatory Surgery Center I'm referred to is a completely independent building and completely independent site that functioned completely separately from an inpatient hospital. Yes, and I would echo that in my Ambulatory Surgical Center in Texas has two ORs and the state has reached out - they’re requiring independent ASCs to register their ventilators because you know that there's a good likelihood that they're going to have to repurpose them.

58:28

Maybe not in our ASC but take the ventilators.

58:33

So, another question that comes from our members, of course, has to do with the financial impact around clinics not seeing patients and of course patients not receiving care. What advice or counsel can we provide to those practices who are not receiving obviously revenues, but obviously have overhead costs and other expenses?

59:00

So, I'll just tackle that to begin the conversation. So as I mentioned our governmental team is working with policy makers to try to get them to Earth, help them to understand the predicament of our community, and help to guide how our community can tap into the resources that might be available since Trump has passed the however many trillion dollar

59:29

two trillion-dollar bill. Also, as Kevin mentioned tomorrow, we are holding a webinar where we're going to have some experts to help discuss the ins and outs of the availability of funds in this bill that's being passed. I don't know Kevin. Do you have any other information you want to add on that? I think it'll be a very valuable webinar. I'm ready to hear what the panelists say. Well, there's at least three areas where physician groups

59:58

and hospital physician groups have been able to safeguard themselves from a financial standpoint. There is no physician group, physician practice, or hospital that is going to get through this entire period unscathed. Our physician group is basically looking at about a 20% hit which is almost 200 million dollars. How do you cover that? Well, we have the potential for Medicare monies to be advanced.

1:00:28

That doesn't exist as an opportunity for IVF clinics or many other physician settings. But extending lines of credit, looking to the next CARES package, and what can be obtained from that, as well as a small business loan that you can get from the first CARES package, are all opportunities to provide extension. I think most of us look at this as a two- or three-month process. You have to you have to weather your cash flow, manage

1:00:58

that appropriately, and then look to the growth that you'll have after that.

1:01:04

There's a series of questions that I think we can put together concerning both viral load and viral  infection of fetal tissues in patients who have had a loss, as well as how to handle the tissues of patients who are infected with COVID. What are the special considerations

1:01:33

in dealing with that for gamete storage and so on.

1:01:40

So, in terms of patient interaction, I'll let Catherine talk about some of the management of gametes and embryos as well. But if we consider where you get your greatest viral load it tends to come from the digestive tract. So, the greatest risk is again, somebody coughs, sneezes, you must intubate someone. Fortunately, that's not something we typically have to do in our practices. The amount of viral load

1:02:09

and its infectivity is not very well sorted out. It's pretty clear that your droplet load and your risk of infection goes up if you're within six feet in the presence of someone who is COVID positive for more than 10 minutes. Again, up until that time, it's not clear what your absolute threshold is. So, most of us have taken the precaution of wearing n95 masks in the presence of any COVID positive patient.

1:02:39

In New York City right now, everyone is assumed to be COVID positive.

1:02:46

Very good. In respect to gamete and tissue storage, since we simply do not know whether the virus survives in liquid nitrogen and we do not know whether there is transmission from one specimen that might be infected to another that is either in vapors or in liquid nitrogen, our recommendation is just simply to handle the samples from a COVID positive patient in exactly the same way as one would handle samples

1:03:15

from a patient that is serum positives for another infectious disease. Obviously universal precautions absolutely must always be used  when handling these specimens. Time will tell. We just simply don't know now.

1:03:32

Will the availability of testing and more and expanded testing for COVID-19 and for the novel coronavirus, will that impact the recommendations of ASRM? And will that impact the care that we are able to provide patients? Well, certainly having more knowledge is helpful and you know, the current tests we’re

1:04:01

predominantly using are PCR-based test so they're finicky test to some degree because you've got to amplify up the RNA and the virus to detect it. Detection and the newer tests appear to be quite good up to 95 % specificity. Unfortunately, we've seen several patients who clearly are at clinically very high risk for COVID infection and they have multiple negative tests before you get a positive test. So yes, more information would absolutely be helpful but just like we did with HIV is a disease you end up needing to have universal precautions when you have a high prevalence of disease within the population. And to the question as to whether the guidance documents might be a revised as testing is increased. This is a tricky question because my understanding is that the need for testing is largely to identify where there are hot pockets, where there may be interventions are needed and resources needed to a much greater degree. So, I think we just must wait and see. We must see how many tests are released, where these hot pockets are. Whether we end up revising the guidelines to specific areas of the country is up for question now.

1:05:31

We just don't know. We're just trying to do our best to do what's right.

1:05:39

So, there are questions about the function of a clinic. So, there are several questions about whether we're recommending that centers or clinics still allow patients to proceed with diagnostic procedures, blood work, hydrosalpingogram and the like, or is the focus strictly to a no contact

1:06:05

telemedicine visit, and if so, who will approve the opening of clinics and what criteria will be used. I think those are somewhat linked questions. So, the answer is we’re discouraging, the task force is discouraging physical management of patients, physical interaction that is not urgent.

1:06:35

Obviously, there are ways to try and mitigate, again no safety guarantee. Those methods would require not only distance but maybe both the patients and all the staff wearing masks because it can be transmitted in the asymptomatic timeframe. And obviously the concern is that may make it safer but you're using available resources that frontline people in hospitals have

1:07:05

difficulty getting. I think at the present time, the recommendation of the task force is to avoid doing treatments that are not that are not emergency type treatments.

1:07:19

What about who's going to order the clinics or who's going to mandate that the clinics be opened? Who determines that?

1:07:32

So, I mean, I think it's important to reiterate that as Kevin said the documents that the ASRM task force are producing have not gone through the normal process of membership surveillance and critique. These are recommendations, they’re guidance documents that are providing recommendations.

1:07:54

We're not and we can't mandate anything. I don't want to be too sort of sensitive and emotional about this, but this is just about doing the right thing. It's not about when can we do this because we want to do it. It's about when should we do this given what's happening in our immediate environment, in our state, and in our nation. So again, these are not regulations.

1:08:23

I mean, I'm English as you know, and you know in England we abide by regulations. Americans don't like regulations, but they will go with guidelines, but these aren't even guidelines. It's a guidance document with recommendations that as a group of experts we felt was the right thing to do. I hope that answers the question adequately. It's hard to imagine doing procedures that could fit into an elective category in a state where elective procedures have been either precluded or prevented.

1:09:02

By Governor's executive order. I would hate to think about what the liability would be if anyone were harmed by infection or your workers were harmed by infection, or another adverse outcome to occur when you weren't following the guidance of either the state or a professional organization. Yes, I agree and the guidance in Texas-

1:09:29

so, we've had documents produced by our Texas Medical Board and produced from the governor that that tend to fit, as I interpret it, tend to fit with the ASRM’s guidance document. On the other hand, there are some clinics that I'm aware of that interpret these  in different ways.

1:09:56

Thank you. There are some questions around masks and MP95 masks. The company that MP95 masks tend to filter particles that are .3 microns or larger, but that the viral particles we are talking about or about .1 microns. How is that then that MP95 masks are effective? And then secondly,

1:10:23

why aren't people just making their own masks? What's so special about these masks?

1:10:34

So M95 masks are designed with an electrostatic layer that basically captures viral particles, as you alluded to Ricardo, down to 0.1 microns in size.

1:10:47

There are other masks which have similar numbers like KN95 or NP95 and those are generally not considered the same level or same protection as N95, which most people use in health care centers for protection against viral infection. N95 is really the standard.

1:11:11

So, the virus is smaller, but it's usually carried on droplets or micro droplets and those are large enough to get filtered out by the mask.

1:11:20

In terms of using homemade masks, homemade masks and any surgical sort of standard surgical masks are good for decreasing droplets coming out of someone's mouth. So, it's good to prevent you from infecting someone else but it is not a filtering mechanism. N95 is a tight fit filtering mechanism. So that all the air must go through the mask itself.

1:11:45

It cannot go around the mask and that's again where the filtration component is important.

1:11:53

Thank you. There are several questions around how to manage patients who require urgent fertility care. If the clinics are being closed or are closed, how are those being managed?

1:12:12

So, I'll tackle that from our experience at Brigham Women's Hospital. So, we have stopped all patients doing regular IVF. However, we are open. The lab is open to take care of these urgent cases and we have I think a retrieval in a couple of days for a cancer patient. So, for a small free-standing clinic who might have a population of patients that need to have urgent

1:12:42

fertility preservation, I would hope that there might be an opportunity for the patient to be referred to a larger clinic with the lab still open. As you probably noted in the guidance, we made it very clear that these urgent cases such as for gonadotoxic therapy and fertility preservation should be allowed to go forward for the obvious reasons.

1:13:10

Yes, and I would say that these embryologists and their staff, they're not fired typically or taking jobs in carpentry or plumbing- they're still out there. And as long as you keep your laboratory open and you need to in order to maintain your liquid nitrogen and the safety of your gametes and embryos, you've still got these highly skilled personnel that can that can be called in to handle these cases.

1:13:38

I don't think typically that's going to be a problem even in freestanding IVF clinics. The ASRM task force guidance supports maintaining essential services and having adequate personnel to do that. With respect adequate personnel there should always be a minimum of two people in the lab

1:14:10

just for obvious safety reasons and for double checks on the IDs of the specimens to make sure that things are done watertight. Thank you. So how do the ASRM recommendations compare to those of other medical specialty societies: Orthopedics, Ophthalmology, and so on.

1:14:38

I think all those Specialties have stopped their, and the word elective was mentioned before and that's kind of a hot-button word, but they've stopped doing non urgent care. So, I'm aware that sometimes people can't get lithotripsy for their kidney stones or they can't get their cataract surgery. So, things that are have an urgent nature or time

1:15:06

is of the essence. Those are generally not excluded by these other associations. I think we're right in line. And when you look at those other associations like the American College of Surgeons, they have an entire series of tiers of urgency where frankly only the highest-level emergency or urgent procedures are being done.

1:15:30

I should add that ASRM is a member of the Council of Medical Specialty Societies (CMSS). And so CMSS is as a group covers more than 800,000 Physicians and 45 Specialties and all these societies have basically similar statements around elective or non-urgent procedures,

1:15:59

around delaying anything that is not an emergency during this period. So, in fact most of our sister societies have taken the same position that we at ASRM.

1:16:18

I think this will be our last question because we're well past our time, but I do think it's important. Lots of questions about geographic and locale, should we be considering individual localities, geography, places, rather than sort of a general kind of recommendation.

1:16:47

So, I would say I think that was considered at the outset and the wisest move was to be uniform about it. And I think it will be considered when we're on the other side of this as well.

1:16:57

But I think one of the things that we recognize when disease spread outside of China, it was very quickly recognized that the United States is a very mobile and very free set of communities. And the exchange of disease amongst those communities unfortunately is very rapid. So, as we're seeing throughout the country, they'll be little hot spots. But frankly, I think it will be a period before that is settled to the point where we're safe. Well, thank you very much everybody and all of those who attended and sent questions in thank you are to our speakers for taking time to do this.

 

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