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69 - COVID-19 and the 1st Trimester: What the ASPIRE Study Could Mean for Your Fertility Clinic, an interview with Dr. Eleni Jaswa and Dr. Marcelle Cedars

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The first trimester of pregnancy is crucial. Organ development is taking place, the placenta is being developed, things that can affect the trajectory of the entire pregnancy, or the baby’s life. But as of now, there is no data on the potential impact of COVID-19 during this critical stage of development.

But soon, that will all change. And what will it mean for fertility clinics once there is scientific data?

On this special live episode of Inside Reproductive Health, Griffin spoke with Dr. Eleni Jaswa and Dr. Marcelle Cedars, two of the Principal Investigators of the ASPIRE study being conducted through UCSF Center for Reproductive Health. This study hopes to reach 10,000 pregnant women in their first trimester and monitor them, looking for any impact that COVID-19 might have on fetuses through babies aged 18 months. They share the ultimate goal of the study, just  how they are going to do it, and what you can do to be involved to help patients make more informed decisions when it comes to the potential risks of COVID-19.

To learn more about the study and how you can get involved, visit aspire.ucsf.edu

This episode was recorded during a live webinar. As the COVID-19 Pandemic continues and new issues arise, we are putting out new information to help you and your fertility business. Follow us on social media for updates on upcoming webinars and how to join them live. Find this information helpful? We’d love it if you’d share with a friend or colleague in the fertility space. 

Need help navigating marketing through this unprecedented time? Check out our COVID-19 Toolkit from Fertility Bridge. 

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Welcome to the Coronavirus Business Response Series of Inside Reproductive Health. Here, you'll be updated on the latest insights on managing and owning a fertility business or IVF center during the COVID-19 pandemic. We put out free podcasts, webinars and articles as soon as new topics arise, so make sure to subscribe to stay updated. The best way to help us in return is to share this episode with someone in the fertility field that would find it useful. Now here's the founder of Fertility Bridge and the host of Inside Reproductive Health, Griffin Jones.

GRIFFIN JONES  0:57  
So I'll introduce our guests, we'll talk about the study that we are here to discuss today and what it will mean for patient relations, what it will mean for the community. It's the ASPIRE study, which is assessing the safety of pregnancy in the Coronavirus Pandemic. It is about the impact of the safety of pregnant women and their babies, particularly with health--particularly with relation to COVID-19 and the first trimester. And so I would like to introduce our guests who are a part of the UCSF study and that's Dr. Marcelle Cedars, and Dr. Eleni Jaswa, who some of you know very well and some of you might be meeting for the first time. Dr. Cedars, Dr. Jaswa, Marcelle, Eleni, welcome to Inside Reproductive Health.

DR. MARCELLE CEDARS  1:53
Thank you.

DR. ELENI JASWA  1:54  
Thanks for having us.

JONES  1:56  
My friend, Eduardo Harriton recommended this topic to me. And when he told me about this study, he was fairly confident that this is the only study like it going on in the world. Can you tell me about why that sword came to you all then? How did it end up being UCSF, and particularly the REI Division at UCSF, that chose to take on this study?

JASWA  2:26  
Yeah, I would say that I'm not sure the sword came to us so much as we jumped on it ourselves. But we have obviously, as a reproductive endocrinology community, been facing a brand new reality, a brand new world with the emergence of this pandemic only months ago of a virus never before seen by our species. And so a lot of really critical questions have been coming up that are immediately urgent and relevant to our patients, to our practice of medicine. And we realized we're in a unique position as fertility specialists to answer some of those really important questions that have not yet been addressed and are really hard to address technically. And with that, I'm referring specifically to first trimester pregnancy exposures for the impact of potential viral infection. So we know that the first trimester is a critical window during which point developing pregnancy, the fetus gets all of its organ systems set up, the placenta, which doesn't quite get the reputation for how amazing and critical it is get set up in the first trimester and that kind of dictates the trajectory of the pregnancy and fetal growth throughout. And yet, generally the first trimester has been historically inaccessible to research because when women get pregnant in the wild, they generally can't get in with their obstetricians until maybe 10 or 12 weeks along, at which point all of these critical processes have already taken place. And so our position as a reproductive community is that we often follow patients from the moment of conception, we participate in that moment of conception. And we have access and systematic tracking of women really early on in pregnancy. And that's a really unique resource for something like examining the effects of a virus during a critical window of pregnancy. So, we found that opportunity and thought that there's no one better positioned than the community of fertility providers in this network we have through SART across the country, into our clinics, to ask these questions really systematically and get this critical, otherwise inaccessible information.

JONES  4:46  
So is that mainly because, to your point, that it's the REI community who is serving pregnant women in the first trimester, typically? They're not going into their OB/GYN before 10 weeks, typically. So is that the main reason? Because simply because the REI community is more likely to have access to these patients?

CEDARS  5:10  
Well, I think we have access to a subset of these patients. Obviously, the percent of patients who get pregnant, who used fertility care is a relatively small percentage of the total number of pregnant patients. So in an ideal world, we'd have a system where all women get prenatal care beginning very early in pregnancy, but the reality is, we don't have that. And so while this isn't a study about fertility, per se, we saw the SART clinics--the Society for Assisted Reproductive Technology--as this incredibly valuable and unique consortium of clinics that do see women, as Eleni said, from the moment of conception, And then we follow them very closely. And so it gives us this window, for instance with SARS-COVID-1, which is not the Coronavirus we're dealing with now, in the very small study, 57% of patients had a miscarriage in the first trimester. Well, if you don't see patients till 10 weeks of pregnancy, you'd never know that. And so we really thought like it was so critical to capture early complications. But then also, as Dr. Jaswa said, to understand the biology of fetal development, placental development, which happens in those first critical 10 to 12 weeks, be able to find out when the infection occurs and try to understand what happens if there's infection, whether somebody's symptomatic or asymptomatic, and without doing a very large scale study like that. This, you won't pick up asymptomatic infections and you won't pick up women early in pregnancy. So really using SART and the SART clinics and asking for their help as a tool, give us this valuable piece of information that actually will apply to all women and all pregnancies.

JONES  7:22  
This isn’t a clinical show, normally, most of our topics are about business development or patient relations or practice management. The reason why I was so interested in this study is because there's so much anxiety out there regarding what are the impacts of COVID-19 and pregnancy. And it is impacting fertility centers--it is causing some people to delay treatment, it could be a reason for fertility preservation. So before we talk about the potential implications though, I'm curious about this sample size, how big do you want this to be? I mean, you talked about the scale, Cedars. How big of a scale do you want it to be? And where are you getting your participants from?

CEDARS  8:14  
So our goal is that we recruit 10,000 women, which is a lofty goal, but the start clinics alone see about 100,000 pregnancies a year. So we feel like that's doable. We also have a validation cohort that we're recruiting from the community so that we can see if the things we find in the infertility population apply to non-infertility patients. But we don't really know and that's part of the problem with doing a study about the Coronavirus is there’s so little that's known. And one of the unique aspects of SART is because it's a national consortium, and if you look from state to state on the impact of Coronavirus and the prevalence for instance, in New York City versus the prevalence in Montana, we're going to be able to look around the country. But if you figure maybe 3% across the board of the population, even with 10,000 women, that's 300. So you have to recruit a very large population in order to have enough positive patients or patients who've been exposed to the virus to get meaningful data. And because we want asymptomatic patients, we have to screen and we have to enroll people with pregnancy as the enrollment and not Coronavirus as the enrollment.

JONES  9:51  
So talk to us a little bit about the methodology. The pregnancy is the main criteria for enrollment and then you’re testing for Coronavirus. How are you doing that?

JASWA  10:03  
Yeah, I would first just add that we've been really encouraged by SART so far in this incredible community because in our first two or three weeks, 76 clinics from 26 states already partnered with this study and are, you know, featured on our website. So we're really encouraged that everybody is really truly in this together as far as participation goes, and the study design and methodology like Dr. Cedars said, this is a prospective cohort study. So the only eligibility is you’re between four and 10 weeks pregnant at the time of enrollment, and then we follow you. So we assume most women almost all will be healthy in the beginning and we follow them through pregnancy ideally, most remain healthy throughout their pregnancy, but there will inevitably be cases of COVID-19. The way that we are following and tracking those cases and pinpointing the exposure with regard to gestational age is through symptom tracking. So using mobile phones, participants answer push notifications with brief symptom screening tools, as well as questionnaires self-reported health outcomes data, but importantly, we're following serology. So women will be shipped packages with blood spot cards and are able to use lancets at home to prick their finger, place blood samples each gestational week through the first trimester on these cards that they can then ship back to us at the end of each trimester and we're able to actually assess for antibodies serology so IgG, IgM responses with regards to where they were in their pregnancy at the time of exposure. But it's pretty amazing technology that doesn't require any increase in risk, any interfacing with the medical system. It can all be done at home in the safety of one's own home and then just shipped back to us to run the assays.

JONES  12:04  
And so you all are having clinics referring patients to the study. Has that just been through SART at this point? Has it been direct to clinic outreach?

CEDARS  12:19  
I think we've done both. SART was very generous. We went through the SART research committee and they were very generous, the SART research committee and the SART executive committee, to send a letter out to all medical directors of their clinics about the study. And then we have specifically reached out to programs that either we know people who are involved in those programs. We're also very interested in trying to make sure we enroll in states that have mandated coverage because we are concerned--if you look at Coronavirus risk, risk with COVID, both severity of disease and death. There's a very strong socio-economic, racial component to that and so we're concerned that our population may be skewed in a direction that limits our ability to have application to a diverse community. And so, we have been reaching out in states that have mandated coverage because their socio-demographic, as well as ethnic racial breakdowns, are different perhaps than states that don't have a mandate or in states that have higher diversity racial ethnic groups, Florida, for instance, or other states that might allow us to enrich the cohort with a more diverse population. So it's been both through the SART infrastructure, but as well as our reaching out to clinics. And then Eleni can talk with you about the sort of community outreach we've done to broaden the implications as well.

JASWA  14:07  
Yeah. And so, like Dr. Cedar said, having a really representative sample is a priority for this study, because the goal, again, as she said, is not about specific implications for infertility per se. It's getting information on pregnancy by leveraging this absolutely unique asset of the SART infrastructure and the REI community to unlock this important time period of pregnancy. So we get information and answers that are important for people all over the world, who are thinking about pregnancy, who are pregnant, and otherwise. In the community outreach arm, we've deployed some targeted strategies, either through influencers using social media, or you know, you said Dr. Harriton gave you this idea to talk about in the first place he's been a champion with outreach, both via social media and other important people who get a good visibility from stakeholders. We believe that really everybody are stakeholders for this, whether it's pregnant patients, families, policymakers, obstetricians, this information will help inform a lot of our behavior and our care for our patients. And so we're using targeted strategies to achieve the most representative sample to get data that applies for everyone.

JONES  15:33  
I think someday Dr. Harriton will have the following needed to fill a 10,000 person study just from a single post, but right now are you tracking where participants come from? If it's community referral or referred by clinic or come through another channel or do you not care as long as you get your cohort as diverse as you feel will be representative?

JASWA  15:59  
I think that real-time tracking is really informative and helpful in guiding our efforts to ensure that we achieve this representative and applicable sample. We've been surprised because some of our targeted outreach, you know, we also spoke with FertilityIQ, we've had some interviews through local news and media, and now we are taking advantage of a lot of different opportunities. Then there's like a thread on Reddit that we had no idea existed and the huge deluge of participants came through that, so some things we can control and others we can't but we are certainly tracking in real time where our participants are coming from in order to achieve and redirect our scientific goals.

JONES  16:41  
Well, that makes me curious--a study this big has to be expensive. And there are agencies that specialize simply in clinical trials and other enrollment for other studies. How are you all being funded at this point? Is this all coming from UCSF? Are there government agencies or other healthcare bodies that are a part of this right now?

CEDARS  17:12  
That's a great question because it is an incredibly expensive study, just based on size alone and the resources to, you know, something as simple as put these blood specimen collection kits together and send them out, but do that for 10,000 women over potentially 16 timeframes throughout a pregnancy. And so it is an incredibly large project. We've had some generous donors who've contributed to the program who have faith in the questions and our ability to answer these critical questions. I just right before I flipped over here, finished the budget for an NIH grant that Dr. Jaswa and myself and Dr. Huddleston, who's not with us today, are submitting for a June 5 deadline. But unfortunately,NICHD, which is the Institute at the NIH that really does studies on mothers and children, or women and children, did not get initial funding to specifically investigate COVID. So they didn't have any specific COVID funds. So we're restricted to a relatively small amount which will not cover really the crux of the study. We have information, we're working with the CDC to try to get additional funding, and then we've been working with our chair, Amy Murtha, in the department of Obstetrics and Gynecology and Reproductive Sciences and with the development office to try to raise money, because this study is so critically important. We feel like we can't--most studies you wait, you have the money, and then you do the study. But because of this crisis time we're in with the pandemic, we feel like we need to move this study forward. And it's a little bit, you know, instead of if you build it, they will come. We're like, going to the end and then coming back to the beginning. So it is a little bit daunting in that sense, but it's so critically important. We feel like we just had to move forward. And people so far have been incredibly generous helping to support this project.

JASWA  19:44  
Yeah, it certainly has been a lesson not only in the science, but the advocacy because it is so crucial that women and children don't get left behind. You know, this isn't our first pandemic and certainly it won't be our last. I think, when you look at what we learned from related Coronaviruses, so two prior Coronavirus epidemics within the past 20 years, SARS and MERS, you can count the number of women on your fingers that got pregnant and were recorded as outcomes in the literature. So it was really a missed opportunity because nobody made it a priority to look at the impact of these viruses on pregnancies and offspring of pregnancies during those times and so we just don't believe that that's okay. That now is the time that we need to get this information and hopefully society will catch up. Like Dr. Cedars said, we've been lucky enough to have some generous sponsors and fundraisers but we have ongoing crowdfunding and are always looking for more to make this vision a reality and make sure, like I said, women and children are left behind.

JONES  20:53  
Because this is gonna be a long study. No? You're going through--we're just at the very beginning. We haven't even left the port yet, have we?. You're following the infant up until 18 months, is that right?

CEDARS  21:08  
Yeah, so our goal is to recruit the women, the pregnant women, between now and the end of February. And so that's a pretty ambitious, short timeline. Again, this is why we're really counting on our colleagues across the country to help with that. And then we want to follow because there could be pregnancy complications, obviously, the newborns, and because of potential concern about neurologic development with first trimester infections, we really want to follow through 18 months where you start to get some of those more subtle outcomes that you might miss if you stop at delivery.

JONES  21:50  
We won't have final findings of this study in...three years?

CEDARS  21:56  
Probably three to five years, but we can answer questions about the first trimester very quickly. Because if we enroll everyone by February of next year by, you know, this time next year, we'll have first trimester data. So we'll have information fairly quickly on some aspects of it. And the more resources we have, as I said, we're interested in mechanisms such as looking at inflammation, particularly because inflammation is so critical to development of the placenta. One of the nice things about these blood cards is we can bank them and then we can utilize them for future analyses. So part of our goal now is to build the infrastructure and get all the material, get the this type of questionnaire data and blood data and pregnancy outcome data, and then as we go on, rely on our resources to hopefully out those pieces and those questions that will help us know how best to care for these women and their children. And as Dr. Jaswa said, the next time something like this comes, we'll have better information. And it's all about information. It's information that's going to enable people deciding, should I build a family now? Should I wait? These are really critical questions. And it's very hard as a physician to counsel a patient when we just don't have that information.

JASWA  23:35  
Yeah, it undermines the whole idea of informed consent when there's really no information. But we're hopeful that through this infrastructure, like Dr. Cedars said, we're able to create really a unique, one-of-a-kind biobank, just with these blood specimens alone of precisely dated gestational windows in pregnancy, and really offer to the world, something that hasn't really been done like this before, in order to answer these urgent questions.

JONES  24:07  
And so how do you envision sharing the preliminary data? Is it something that you plan to do regular updates? If so, when does that start? Is it something that you'll, as you come across what you believe is starting to become a trend, you'll write about that? How do you plan to update the preliminary data?

CEDARS  24:28  
I think that we want to make sure there's certain--there's different things to update on. One is just the progress of the study. And we really want to engage the participants in the study themselves because they're critical to what we're doing. We want to engage the programs to see the value. I mean, from a program standpoint, we talk to our colleagues around the country and as Dr. Jaswa said, we don't know what to tell our patients and so for some of the people who are collaborating with us, they look at this as sort of, if you get pregnant, you need to do this study, because this is how we're all going to get answers. And it's really part of all of us being part of the solution. And so I think there’ll be regular updates on the website and newsletters we're going to send out quarterly that update both programs and our participants in terms of how the study is progressing. And then I think we want to make sure that when we start to produce data, scientific data, that it goes through the same rigor, that we're not getting out there so fast that we don't believe that we have data that we can support. So, there's different types of data that will come out as the study progresses, but it's going to be critically important to maintain a dialogue, both with practices and with our participants, through the course of the project, because both of them are so critical to our ability to do this and to get these answers that are so sorely needed by the population right now.

JASWA  26:05  
We appreciate, certainly, the urgency of this information and want to make whatever scientific conclusions we can in real time, but there's certainly a balance. Because just the same way that some of these tests were bad tests, and using a bad test and changing your behavior on the basis of that, is probably worse than not testing at all. So we want to be really mindful, systematic and measured with the data as far as from a scientific rigor perspective. So understanding that the information we produce and interpret and will potentially affect behavior, and so the goal is to be as scientifically rigorous as possible.

**COMMERCIAL**

Hi everyone, it's Griffin. This is the break in the show where normally, I do a little commercial for our small engagement. And we do have a small engagement that's relevant to the COVID-19 business response. If you're cutting marketing. if you're trying to bring back your people as quickly as possible. If you're trying to build a cache of treatment ready patients. We do have that, but I would rather use this break to just ask if you find this useful if you would share it with a colleague, either via email or on social media. We're doing everything we can to put out as many webinars, articles, free podcasts, all free resources to include as many people from the field as we possibly can to give you resources on how to manage and operate a fertility business or an IVF center during this time. And it's changing so quickly. 

So if you find this useful, I would really appreciate it if you would please share it with a colleague via email or via social media and help us grow the audience, but only if you find it valuable, and hopefully you are. Now, back to your program.

JONES  27:55
What are some of the implications for fertility centers if you do come across--if three years from now or earlier, you're starting to find bad news, if there are real negative effects because of COVID-19 in the first trimester of pregnancy, what does that mean for the REI clinic?

CEDARS  28:15  
I don't know that it means anything different for the REI clinic than it does the general population. There's been no prohibition from ACOG--American College of Obstetricians and Gynecologists--which is kind of the parent organization for obstetrics and gynecology that has suggested that families should delay childbearing or should not get pregnant now. You know, the concerns that were raised with Zika, for instance, where it became very clear very quickly about this birth defect, and we would counsel patients about avoiding pregnancy if they went to high Zika areas, there hasn't been that kind of concern or level of risk with Coronavirus. So I think that from a sort of a liability standpoint, as Dr. Jaswa said, we don't have information. I think it's part of the reason that as a community--and I’m on the ASRM task force that looked at the Coronavirus--and it's part of the reason we suggested a pause in treatment in March, because there was this new virus. It looked like it was coming to the US in gangbusters if you looked at New York, and we didn't know what the risk would be. We do know that a fever in the first trimester from any cause, can increase the risk for miscarriage and can increase the risk for birth defects. And we knew fever was such a prominent component of Coronavirus or of COVID, of the infection itself, that we felt like we had to put a pause. We still don't have a lot of answers, but one of the things the pause did, and everybody has seen those graphs and we flattened that curve, the good thing about flattening the curve is we're not going to overwhelm our healthcare system. The second thing about flattening the curve is the individual risk of getting COVID is quite low in most places. And but it also means the tail for that spread of Coronavirus through our country is quite long. And it may be 12 to 18 months before we have herd immunity or a vaccine. And so with a decreased individual risk and knowing this long timeline, it's very hard to tell certainly our infertile patients, but even general patients or general women who are thinking about getting pregnant--usually it's one of those things when you're ready to get pregnant, you're kind of ready to get pregnant! And so to say, Nope, gotta wait 18 months to do that. That's a pretty hard stop. And so we felt like it’s balance, and we still caution patients, all the things that you should be doing anyway, good hand washing, face masks, social distancing, that's going to need to continue for quite some time in our society. And so it's a balance as everything in life is. So I don't think this is going to come back to fertility clinics any more than it will come back to the obstetrician or anyone else who's making a decision about whether this is the right time to build a family.

JONES  31:37  
I wonder if those implications are the same, though because the obstetrician doesn't necessarily--I mean the obstetrician practices obstetrics, but perhaps also practices gynecology--where the REI’s job is to get people pregnant. You mentioned that there wasn't any mandate from the CDC or guidance I should say from the CDC or the WHO about the general population desisting and attempting to get pregnant. But what if there was a study with 10,000 people done over the course of three years that found that the harm was significant? Is there not a different implication for REI clinics?

CEDARS  32:16  
I don't think so because I can't make decisions today, based on data I have three years from now. And I can't be held to a standard of having to know that information in the context of a decision I make today. I think we counsel all our patients about what we don't know. And there's frankly, much more--I mean, we have some very reassuring data about COVID. One, it doesn't look like women who are pregnant get sicker when they get COVID. And that's important because even something as simple as the common flu--when you're pregnant, and you get the flu, you can get much sicker than someone who's not pregnant. So that's good news. And it's not that you don't get sick, but you don't get sick at any greater rate than a woman who's not pregnant. The second good thing we know is it doesn't look as though there's direct fetal, or direct transmission to the fetus, although there have been a few studies that have started to question that, but there's certainly, it's not a widespread phenomena in terms of when people have looked at amniotic fluid and they've looked at the fetus, or the newborn themselves. So those are all reassuring things. The kinds of things you can find in the first trimester can be very major abnormalities like you saw with Zika, which we don't think we're going to see with COVID based on the data that are available, though granted, very limited data on first trimester infections, even from China when the virus was new in December, but these pregnancies have had ultrasounds and there's no obvious developmental or anatomic abnormalities. So there's lots of good things, or reassuring things we know, the kind of things we're looking for are much more subtle. And we won't know them for many years to come.

JONES  34:20  
Even if the findings do conclude that there is harm in the first trimester that, by that point, there would be a vaccine? I suppose that--not asking REI clinics to make decision now based on data that they from three years from now, but if in fact that that data--

CEDARS  34:38  
Sure, I mean, it's like now we know that Rubella or German Measles, if you get infected when you're pregnant, can cause birth defects. So one of the things we do with all of our infertile patients, is we check to make sure they've been vaccinated and are immune to rubella. So if it turns out that there's a risk with COVID, we may add that to our list along with varicella or chickenpox and rubella, we'd add COVID. So there are things we're going to do that we will then apply, whether we're in a gynecology practice or an REI practice, but we can't be held to a standard for information that we don't have.

JASWA  35:19  
Yeah, and I would even add that I think there's more harm to not doing the study and discovering those risks, then actually getting information to empower that decision-making, both for patients’ autonomy in determining whether or not they are willing to accept a known risk is very different than accepting an unknown risk. And also being able to potentially to change their behavior, whether it's by social distancing or hopefully a vaccine will become available. Understanding these risks, then you can truly participate in shared decision-making in an informed way. And perhaps there won't be risks and our discoveries are reassuring or even in a fantasy world there’s something protected about pregnancy. All of that information will be really empowering regardless of whether there are potential harms or not, for patients to make these decisions. I think it's the fear of the unknown that can be the most dis-empowering and unsettling for folks. So just being able to have trustworthy data to understand how to balance risks and benefits, and potentially how to change behaviors to offer protections will be really important.

JONES  36:30  
Before we conclude, I have just some questions, because we do have some practice owners on this call, we have nurses, we have practice managers, and we'll have many, many more listening to the podcast. If they'd like to enroll patients in that, how do they do that in a way that's helpful to you and easy for them?

JASWA  36:51  
Yeah, our goal is certainly to make this process as easy on collaborators as possible knowing that everyone's busy and has a lot on their plate. The primary role of collaborating clinics is just to direct patients to our website, which is aspire.ucsf.edu. And from there, the patients self enroll, submit their own contact information, and we take everything over from that point. So the goal is just that practices encourage their patients to sign up by visiting our website. We send colored flyers and other recruitment materials to all collaborating clinics to make this again, super easy, where the whole role of the collaboration is just to help get the word out and encourage folks to participate. The IRB at University of California San Francisco has made it such that collaborating clinics don't need their own independent local IRB review, again, they're just connecting patients to this interface to sign up for the study.

JONES  37:56  
And what would you say a little bit more about what's in it for them? I think that one implication I can think of is that, you know, the seven and a half week ultrasound, people are probably getting asked the question, what if I get COVID-19? Or my coworker had it last week and she wasn't wearing a mask. And so I think there's probably a lot of anxiety at that point that REIs are hearing and IVF coordinators and nurses are hearing. Not to say that this would necessarily alleviate the anxiety, but it is something where previously, we just didn't have anything that we could give someone as feeling in control. I think that if you are between four to 10 weeks pregnant and this is the concern being relayed that this is something that fertility centers can direct you to. What else would you say is in it for the center?

CEDARS  38:53  
I think it lets their patients know that they care about this. That they understand it's an issue and that they want to be part of the solution. Because right now, we have a big question and a big problem. And I think that programs, by joining with the ASPIRE network, can show that they want to be part of a solution. And, as you said, it empowers the patients to be part of the solution. And with our system of frequent questionnaires, they may pick up on symptoms that they didn't know they had that are relevant. Those questions change as our knowledge about COVID changes, for instance, absence of smell or things that weren't on the COVID checklist two months ago that are on the COVID checklist now. So they're going to be getting updates. And in our quarterly newsletters and on the website, as we gain more information as soon as we have information and we can validate it, they're going to have rapid, easy access Both the program's so they can share it with their staff and patients, and the participants will have that information. So I think, both this sort of sense of being part of the solution and when their patients ask those questions, being able to say, you know, we don't know, but this is how we're gonna find out and how we're going to be able to answer that.

JONES  40:21  
Dr. Jaswa would you have anything to add about the study that you'd want the REI community to know?

JASWA  40:31  
I just think, you know, there's a lot of darkness in the world right now. And it's nice to be able to participate in something to make progress for everyone to move the needle forward, to get urgent information to care for our patients, our pregnant women, their families, their future babies. I think we're uniquely positioned to make a real impact and a real contribution on a big scale and we should take advantage of that opportunity. I know I for one, am inspired by the collaborative network, despite a lot of suffering that's going on with COVID. I think a lot of people have come together and been inspired to make an impact, to help people, to inform their practice and their patients in a positive way and have been just inspired by people coming together from all over the country to make this a reality. And so I think by participating as a network together, we will be able to achieve a lot, so I'm really grateful for that opportunity.

JONES  41:35  
Dr. Jaswa, Dr. Cedars, Eleni, Marcelle, thank you both so much for coming on Inside Reproductive Health.

JASWA  41:42  
Thank you so much for giving us a voice here.

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