Ep 301: How Do You Research Your Way Out of Infertility: Research in Fertility Care

  Fertility Docs Uncensored is hosted by Dr. Carrie Bedient from the Fertility Center of Las Vegas, Dr. Susan Hudson from Texas Fertility Center, and Dr. Abby Eblen from Nashville Fertility Center. Today, they had a special Guest: Phillip Romanski, Associate Research Director of US Fertility. He is also an Assistant Professor and Associate Program Director of the reproductive endocrinology fellowship at Mount Sinai. In this episode, the docs explore how research shapes the future of fertility care. As Associate Research Director for US Fertility, Dr. Romanski shares how the organization leverages its extensive national data to support studies that directly influence patient outcomes. With eight to nine active clinical studies, patients can visit the US Fertility website to learn about current opportunities to participate, helping advance science, even if the immediate benefits are for future patients. Dr. Romanski highlights a recent study examining development in embryos that initially appeared to have abnormal fertilization. Surprisingly, many of these embryos progressed to the blastocyst stage, and a significant number were genetically normal. This information may help increase the number of viable embryos for future transfer. He also discusses a recent study with unexpected results: a comparison of fertilization outcomes between ICSI and conventional insemination with frozen sperm. Traditionally, eggs are fertilized with ICSI when using frozen sperm. By dividing eggs from individual patients and comparing ICSI with conventional insemination, the team found no difference in fertilization outcomes. This finding could reduce unnecessary embryo manipulation, minimize risk, and decrease costs for patients. This episode takes a fascinating look at how research today is improving the fertility treatments of tomorrow. This podcast was sponsored by US Fertility. 

Transcript

Susan Hudson (00:01)

You're listening to the Fertility Docs Uncensored podcast, featuring insight on all things fertility from some of the top rated doctors around America. Whether you're struggling to conceive or just planning for your future family, we're here to guide you every step of the way.

Abby Eblen MD (00:22)

Hi everyone, we're back with another episode of Fertility Docs Uncensored. I'm one of your hosts, Dr. Abby Eblen from Nashville Fertility Center. Today I'm joined with my lovely and talented co-host, Dr. Susan Hudson from Texas Fertility Center.

Dr. Carrie Bedient from the Fertility Center of Las Vegas.

Carrie Bedient MD (00:38)

Hi!

Abby Eblen MD (00:40)

And we're also joined with our very special guest today, Phillip Romanski. He is the Associate Research Director of US Fertility. He's also an Assistant Professor and the Associate Program Director of the Fellowship at Mount Sinai. And he's gonna talk to us today a little bit about US Fertility and the research that we're doing right now to help patients. And so, but first, he was telling us a little bit about some of his hobbies. So you were telling us about running some marathons in some cool places it sounds like.

Phillip Romanski (01:09)

Yes, absolutely. Thanks for having me. It's great to see you all. I'm really excited to join today. Yes, actually just earlier, right before this, I just got back from a long run, being that it's the weekend. I do spend a lot of my time outside of the office running as my main hobby and way to stay active and get outside. Since I'm based here in New York City, It's important to do that, I find. I run a few marathons a year. This year's been a busy year. I was running Boston earlier this spring, and Berlin is another big major marathon internationally. I ran that this past fall. And I just find it's a great way to get out and meet a lot of people. It's a great community and do a little traveling at the same time.

Abby Eblen MD (01:54)

So, Phillip, you need to come to Nashville and do the Rock and Roll Marathon here. We have country music bands, as you go along. It's a really fun marathon. You should do it sometime.

Phillip Romanski (02:03)

Yeah, I've heard of that series and I hear those are a good time. Have you run that one yourself?

Abby Eblen MD (02:09)

I've never run a marathon. I've run a half marathon a couple of times. Carrie's run some marathons though. 

Phillip Romanski (02:13)

All right.

Carrie Bedient MD (02:13)

No, I do the rock and roll half pretty much every year because it's there's two times a year where they shut down the Vegas strip for traffic and the rock and roll is one of them. So you run up the strip at night and I like running that one because they've got rock and roll. They've got country. They've got everything you can imagine and it's in the middle of Vegas. And so it's entertaining. It's February, this next year. So it's usually good weather.

Phillip Romanski (02:36)

Okay.

Nice. that sounds that sounds really fun. One of my favorite races to run is the New York City Half Marathon, which is usually in March, but they shut down Times Square for that one. So get to run through that area, which is pretty neat.

Abby Eblen MD (02:51)

So do you have to qualify? I you have to qualify for Boston. Do you have to qualify for the New York as well?

Phillip Romanski (02:56)

That's one. Yeah, you can qualify. I usually try to qualify for the races just because it's the simplest way to get in, but a lot of them have opportunities to fundraise and ⁓ get in through charity and things like that. So there's a few different ways that you can usually enter, but it's become one of those sports and hobbies that has just blown up really since COVID, I think, got a lot of people into it. And now there's a lot of social media influencers that are big runners, but every year each race just sells out quicker and quicker. And some of them are really really tough to get into which is great for the sport but a challenge at the same time to play on the calendar.

Susan Hudson MD (03:37)

What's the most unusual place you've run a marathon?

Phillip Romanski (03:40)

Yeah, so actually, gosh, was it last year, I think, I ran a marathon in Switzerland in the the Alps, a group of physicians in the US fertility network. There were probably seven of us that went out there and, and we raised a lot of money for for…

Abby Eblen MD (03:47)

I remember that because I contributed to that. remember that.

Phillip Romanski (04:02)

Thank you for doing that. Yeah, we had a lot of people contribute in and that was great. We were able to award treatment cycles to a handful of patients that really needed it. And this was a unique marathon because it starts in the Interlaken area, at the base, and it just goes straight up the whole way. And you end up in the glacier near the top of Jungfrau.

It's a special race. It was a clear day. We were real fortunate. It was just absolutely beautiful. And the communities out there get really into it. It was a brutal course, we had such a good time.

Abby Eblen MD (04:37)

I'm guessing you must have had to train in hills and stuff ahead of time because I don't know how you couldn't just run straight up a mountain.

Phillip Romanski (04:44)

Yeah, the best of your ability if you try. The altitude is the hardest part, really. That's what got me in the last six miles was getting up at the top. That was tricky.

Abby Eblen MD (04:48)

Well, very cool. Yeah, I think I'm not gonna be running anymore half marathons, but it was fun while it lasted, but no more for me.

Susan Hudson MD (04:57)

Bless all of you runners out there.

Carrie Bedient MD (05:05)

But before we're going to do that, we're going into a question.

Abby Eblen MD (05:07)

Okay, yes. So let's do a listener question. Susan, do you have any questions for us?

Susan Hudson MD (05:11)

I do. Hi, I love your podcast. It has been so helpful for my IVF stress. Thank you for listening. My question is about what can be learned from the attrition of eggs retrieved to embryos. I'm a 35 year old; husband, 36 with recurrent pregnancy loss, AMH 3.59, baseline follicles 13, full RPL workup found nothing. My firstborn was in 2023 without complications.

They've been trying for over a year with three miscarriages at five, nine and five weeks. Did a microdose Lupron flare stim cycle with 17 eggs retrieved, 10 mature, six fertilized and two blasts, both AB. I triggered at day nine with estrogen over 6,000. Wondering if there's anything to be learned here. What do you typically look for to stay the course or make changes? Thanks.

Carrie Bedient MD (06:01)

All right, Phil, what would you do?

Phillip Romanski (06:02)

Ha ha ha!

So that's a great question. when I'm thinking of patients' stimulation protocols and outcomes, and the first thing I always think to myself is, did they respond as I expected? Did I get the yield of eggs that I was anticipating, given their ovarian reserve? Was the maturity and the fertilization and the blastulation all in line with what I would expect? And then if we're doing PGT, I'm looking at the euploidy,

seeing what that looks like compared to their age. And sometimes a patient goes through a treatment cycle and unfortunately doesn't have a successful outcome, but everything else in terms of the attrition is right in line with what we expect. In cases like that, I typically talk to patients and discuss, a component of this certainly is just a numbers game. Unfortunately in that particular round, those eggs, the sperm just didn't quite come together to yield a good outcome.

I often prefer to maintain the course and I tell patients sometimes if we're changing too many things, then it's like we're starting from scratch all over again. Whereas if we otherwise had the outcome we expect, then we can use a lot of that information to improve upon and tweak some of the changes in the subsequent cycle versus if somebody has a lot fewer eggs or much worse egg quality than anticipated. That's where I think about.

Maybe we should look at some different protocols or changing the timing of when we're doing the trigger and things kind of along those lines.

Abby Eblen MD (07:31)

Okay, yeah, so mean she ended up with two blasts, so I mean I think that's pretty reasonable.

Susan Hudson MD (07:36)

Reading between the lines though, she did a microdose Lupron flare. So, she HCG triggered with a estradiol of 6,000. So I would venture to read between the lines that our maturity was probably because she had a bajillion follicles and they didn't let them get bigger.

I would say, knowing you're going to have such a robust response. I would probably do an antagonist protocol or a provera protocol so that I can let your estrogen level get high and Lupron trigger you and keep you safe. You triggered on day nine. Most people get triggered somewhere between day 10 to 12 and maybe starting off a little bit more gently, but letting you go further and let those big follicles get bigger. Because 10 mature eggs is still a great number, but if we're trying to tweeze out things in between, I think that lower and slower and being able to, I mean, we never want your estradiol to be 6,000, but we've all triggered people at 6,000.

But if you have a lot of follicles that will accommodate for that, that's going to get you to a better situation.

Abby Eblen MD (08:53)

The bigger question is why did they use a microdose lupron flare? Because you would think that if somebody responded that well, you'd think their egg count, their AMH would be pretty good. It's an older protocol. And like you said, like we all say, the art of art is, you know, being able to pick the protocol for the right patient. Sometimes as best we try, the protocol that we choose maybe doesn't go so great. Like Phillip was saying, a lot of times you regroup after you see the patient and you go, hey, this is...not the greatest protocol for you. And like Susan said, I think doing it with a Lupron trigger and antagonist cycle probably would be a lot better for this patient and hopefully we'd get more eggs.

Carrie Bedient MD (09:27)

Her AMH was 3.59 and so that gives some background to know, okay, we can push in a different way, do the antagonist cycle and see what else we can get. In this case, the attrition that we're seeing, the 17 down to 10 is likely a function of trigger timing and follicle size like Susan mentioned. The 10 down to six, that would make me wonder how many of those follicles that were considered matured, matured late.

They came out almost mature and then they matured while they were in culture, and maybe they were a little bit less likely to grow. So that's why only six successfully fertilized and two blastocysts out of six fertilized is great. That's a beautiful percentage. You probably have very good things to look forward to in your future. Cause those are nice numbers when you really dive into it and you will do well even if you may have to do another cycle.

You should do really well and get what you want.

Susan Hudson MD (10:22)

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Abby Eblen MD (11:24)

So today we're gonna talk about a really interesting topic. We're gonna talk about research and the research that we do, I know in our field, we do it to try and benefit patients and patient outcomes. So you're gonna talk a little bit, today about some of the things that US Fertility has done and is doing in terms of research.

All right, so let's dive into US fertility and research. Phillip, tell us some interesting things that US fertility is doing now that hopefully will help our patients going forward.

Phillip Romanski (11:47)

Yeah, absolutely. US Fertility, we've got a pretty robust research division and we place a lot of focus and emphasis on really leading the field forward. And we're such a large network with clinics that are really spread geographically around the entire country. Our patient population is very representative of the country as a whole. Given that and given the size of our network, we feel it's really important to give back and to be able to do research, either retrospectively with a lot of the data that we have from patients who have completed treatment cycles or prospectively to help figure out what are going to be the next innovations when it comes to treatment and medications. We've got a large group that's constantly working on that, lots of physicians throughout the network that are very research-focused, as well as a handful of fellowship programs. We have five different fellowships in our network that are all contributing to the research that we're doing. There's been an interesting shift in the last five years or so, there was a lot of innovation going on looking at how do we improve our treatment protocols and how do we improve outcomes for patients as we're doing more obviously antagonist protocols, we're doing a lot more cryopreservation and then PGT comes along. Now we're at a point now where those outcomes overall are for many patients quite successful and the last frontier that we still have such a difficult time overcoming are the egg quality issues. I think where research is really focusing on now is how do we improve that number for patients? How do we improve the number of usable embryos? As I was mentioning earlier, I mean, the more eggs a patient can have, the greater the embryo yield, the better likelihood that they're going to be successful with fewer treatment cycles. And so that's where I see a lot of the research focusing on now, I find that to be really, really fascinating. There was a time where we look at embryo development and sometimes we get these abnormal outcomes that we're not really sure what to do. And I'm talking about when we're looking at embryos in the lab, we're looking at fertilization, see an egg perhaps looks to be abnormally fertilized. In that case, we're worried that maybe that is not going to be a healthy embryo. Maybe that's going to result in a miscarriage or something along those lines. For a long time, those weren't embryos that we were transferring. And some clinics aren't even really culturing those embryos out because they look abnormal. We're worried about them. But we now have the technology and with some of the different PGT platforms to determine whether those are indeed genetically normal healthy embryos.

We published a study just earlier this year where we focused on some of those eggs that appeared abnormally fertilized, what we would refer to as having no pronuclei or one pronuclei. What's considered normal, what we look for is two, one from the sperm, one from the egg. But some of these embryos we were culturing out and finding that actually some of them did develop into really nice blastocysts. Then when we could biopsy these and do PGT on them.

Looking at SNPs, we can determine whether if it's a euploid embryo, whether it has one set of chromosomes from the mother and one set of chromosomes from the father, what we call biparental diploid. But that tells us that that's actually a completely normal, healthy euploid embryo. We've been able to confirm that in some of these what would otherwise look abnormal embryos. And by doing that and using this technology, we found that actually we can use that to increase the again the number of usable embryos that patients have available for transfer which I think is a really exciting innovation.

Abby Eblen MD (15:25)

So ugly embryos can make pretty babies is what you're saying.

Phillip Romanski (15:29)

That's exactly what I'm saying. You can see it all. You can see it all.

Susan Hudson MD (15:34)

So if we have a listener out there who maybe has had not a great IVF outcome, whether it's one cycle or four cycles, how do they go about finding out about clinics or networks that have research and how can they possibly get involved?

Phillip Romanski (15:53)

So the simplest way is to talk to their own clinic. If they're already seeing a physician, a lot of these decisions are made at the individual clinic level or at the individual laboratory level. So specific to what I was just discussing, that would be a good question to find out, is that something that clinic's lab does when they're evaluating their embryos? But a lot of clinics that are involved in research, of course, are very proud of that and often that's going to be published on their website. So, US Fertility, for example, on our website, we publish all of our presentations, all of our publications, and that's available. We want all patients to be able to see what were the innovations that we're coming up with and some of the findings from our studies to help change the way that people are practicing. And so that's available for both physicians and patients to utilize.

Susan Hudson MD (16:43)

RMA of New York is a global leader in state-of-the-art reproductive medicine, serving as Division of Reproductive Endocrinology and Infertility at the Icahn School of Medicine at Mount Sinai. Led by an integrated team of physicians and scientists, RMA of New York is renowned for its pioneering research in the field and for delivering high IVF success rates. With locations across Manhattan, Brooklyn, Westchester, and Long Island, RMA of New York has helped thousands to build the families of their dreams for more than two decades and counting.

Abby Eblen MD (17:14)

Could you speak a little bit about the quantity of data and how that's important in research and why US Fertility is in a good position to be able to provide some of that information for patients?

Phillip Romanski (17:23)

When it comes to research one thing that is incredibly valuable and you know powerful really is all about the numbers because the more treatment outcomes that we're able to evaluate, the more precision we can have when we're doing our statistical analysis and we're determining whether there's truly a difference between these two patient populations. Imagine you've got patients going through a treatment cycle and we add a particular intervention. If we add that to five patients and five patients don't get that.

There's such a variety in outcomes that can occur. We're not really able to interpret those results with any level of confidence to say, yes, indeed, that intervention is helpful or not. But if we can apply that intervention to 20,000 patients and compare it to another 20,000 that did not get that intervention, and we see a difference in outcomes between that groups, what we find in our statistical analysis is a very tight, precise, what we call an effect estimate, but will tell us indeed whether there's a true difference there.

And that's how we determine whether certain exposures, certain interventions actually are beneficial or in some cases potentially harmful. And when you're doing research at an individual clinic level, maybe that clinic does 500 cycles a year, 1,000 cycles a year, 5,000 cycles a year. And so it can take many years in order to amass enough patients, especially if you're looking at a specific diagnosis or specific treatment protocol.

Whereas when you've got a large fertility network with tens of thousands of treatments of cycle per year, very quickly, we can ask questions that haven't been able to be asked before with any level of confidence because of the power of the size of our data set. The other thing I've found that we're really making a lot of headway on in recent years is we're able to look at a lot of rare exposures and rare conditions. And so some of our fellows are currently working on projects looking at outcomes and patients that have Turner mosaicism, which is not something that we see all that often. But again, when we look at it throughout our network, we certainly have enough cases where we can start to see what the outcomes look like for those patients. And then that helps us to counsel those patients when they come in the door. So those are the two areas where we're really able to push the research forward in novel ways that hasn't been done before. We just got back from our big annual conference, the ASRM conference.

And that's where a lot of this research is getting presented every year. And our fellows had over 60 different research abstracts that they were presenting oral presentations, poster presentations, and won a handful of awards, which we were really proud of that work. But a lot of that gets back to the data that they're working with and the ability to ask these questions. I'll tell you about one of my fellows where I practice at RMA in New York. I'm very proud of her. Dr. Bayefsky had multiple presentations, but she won the award for the third overall prize paper of the entire conference. That particular project was looking at outcomes for patients that froze their eggs age 35 and older.

Abby Eblen MD (20:24)

What did she present, Phillip?

Phillip Romanski (20:34)

Looking at the outcomes when they came back to thaw those eggs. Because many patients in an ideal scenario are coming to freeze eggs before age 35, but we all get those patients that just didn't really think about it. And now they're 39 and 40, and all of a sudden they realize that time is running out. And we don't have a lot of data to help counsel these patients on what are their success rates if they decide to do this treatment? And that's so crucial for a lot of people to decide, is this a treatment that they want to go through? And for a lot of patients that cost a lot of money, it's a big time investment. And so it's so important that they understand what their outcomes might look like. And so she was able to report on what those outcomes were. And really we saw that even patients in their 40s, early 40s had what I would consider reasonable success rates, but using this data now we can apply this at the clinic level, which has changed a lot of the counseling that we're able to do.

Abby Eblen MD (21:26)

That's great.

Susan Hudson MD (21:32)

An important thing for our listeners also to remember is sometimes this research is one of those pay it forward types of things. It may not definitely affect your cycle, but it will help us gather more and more information for people who are coming through fertility treatments in the future.

Carrie Bedient MD (21:51)

How should patients think about when they are approached about a cycle? So a lot of this data is collected by looking retrospectively, meaning the data is already there, and it's somebody who's combing through it. But a lot of the really gold standard cycles that we do are prospective RCTs, meaning you set all the guidelines, all the rules from the beginning, and then you just follow what happens going forward. And so those are the cycles where patients actually have to consent to something to say, yes, I want to be a part of this.

Susan Hudson MD (22:19)

What's an RCT?

Carrie Bedient MD (22:21)

So RCTs are randomized controlled trials where you take a group of people and split them into two where one group is exposed to whatever it is you're studying and the other group is just going forward with whatever their course was naturally gonna be. There's no real interference. And so it allows you to compare two groups that are nicely matched with each other so that everything else is the same. The only thing that's really different is whatever that intervention is, whether it's a med, a protocol, a procedure, whatever it may be. How should patients think about this when they're approached in the clinic saying, hey, we're doing this study, do you wanna be a part of it? What questions should they ask and how should they approach it?

Phillip Romanski (23:04)

Yeah, I mean, that's a great question because these are definitely things that patients might get offered or that might be discussed with them at some point during their treatment for fertility care or some other type of medical care that they received. The most important thing is that the patient is completely informed as to the type of research that's being done, what is already known about that particular intervention and what isn't known about that particular intervention. The questions that the patient should want to ask are exactly what's going to happen to me? Is there anything that's going to be done differently during my treatment cycle that otherwise wouldn't be occurring? So that they understand what's their potential level of...risk would be what they would want to understand. Understanding that these studies are designed to keep risk as low as possible when it comes to the patient. Any study that would potentially be harmful to a patient typically is not one that's going to be approved but any risk and benefit should be discussed thoroughly with the patient before they agree to participate in some of these trials. And as you mentioned before, when patients participate in a trial, typically this is outcome data that likely is not gonna benefit that specific individual. So patients that choose to participate in these randomized trials, usually they're doing it for the greater good. And so we can help to understand better the treatments that we're offering patients so that when that similar patient comes through a few years from now, we'd better understand ⁓ what protocols or medications or things like this that we should be using for them. But the risks and benefits and what's going to change for them during their treatment. And sometimes the answer is nothing. A lot of times with these randomized trials, they're gathering information or maybe blood samples that are already occurring from the blood draws that they're having in the clinic to make it as simple as possible. We know most patients aren't going to agree to come in for extra clinic visits or extra blood draws, and we certainly don't want to have to do that for a patient if they don't need it. Studies that typically involve that, usually there's a lot of incentives added to the study. Perhaps the cost of some of their treatment is covered or their medications might be given at no cost, things like that to compensate the patient for their time and ⁓ willingness to participate in the research.

Abby Eblen MD (25:30)

Phillip, on a different but yet related question, can you tell me about a study that you guys have done in the recent past where you found something surprising and unexpected? Because for me, the best part of research is finding out what the result is. Oftentimes when you do research, you sort of think you know what's going to happen, but then something surprises you. So I'm just curious if you've had a study like that recently.

Phillip Romanski (25:49)

Yeah, that's a great question.

I'm trying to...

rack my brain to think some things that have been surprising. Actually, through some of our physician level conversations between clinics, one research study that we conducted a couple of years ago, we were looking at ways to fertilize eggs when using frozen sperm. And what we realized is that there's not really any good data out there to evaluate whether normal, what we call conventional insemination, where you're just putting the sperm around the egg and letting it sort of fertilize on its own, versus ICSI, where you're selecting the sperm and injecting it into the egg. There's not really any data out there to suggest whether the freeze-thaw process of the sperm affects that conventional insemination method. A lot of people's default in the lab is to go ahead and apply ICSI.

Assuming that perhaps the fertilization is going to be worse if you do the conventional insemination there.

But we found that we actually had a few clinics and a lab that their default was to do conventional insemination without any data to suggest that that's harmful. And they reported anecdotally that their success rates were as they expected. They didn't see anything abnormal there. And so that was one retrospective study where we looked at that exact question. If we do conventional insemination or ICSI when we're using frozen sperm, what is the fertilization and embryo development look like. And what we found was that with the conventional insemination, the fertilization, embryo development, all of these things was at least as good and in some cases seemed to maybe even be better than when ICSI was used to fertilize these eggs. Whenever we do these retrospective studies, this is often the first step to understand some of these associations, but importantly, to make any definitive conclusions, we often want to follow that up with a randomized trial where we can account for a lot of these confounding variables that might influence some of the outcomes, but not really be related to the exposure. So we're actively enrolling in a study we call it the SISTER trial, where patients that are using frozen sperm undergoing IVF.

We're doing what's called a sibling oocyte design where the eggs that get retrieved, we split them in half and then half of their eggs will undergo conventional insemination. Half of them will undergo ICSI and then we'll be able to follow that out to see what the development in the lab looks like for those patients. So we're really excited for that and that study is currently underway.

Carrie Bedient MD (28:13)

When we have patients come in who say, I've done my research, and they propose whatever idea or plan, as a researcher and as a clinician, how do you look at that information when a patient comes in and says, I've done my research, da-da-da-da-da, this is what I found? How do you look at that, receive it, think about it, and then apply it to whatever their case may be?

Phillip Romanski (28:36)

Yeah, that's a great question. And honestly, that's one of my favorite things that a patient can say to me is that they've done their research. They've been out there, they've been reading, they're educated. Because automatically, I know that that conversation we're about to have is going to occur at a higher level. I don't have to spend that time discussing the basics with that patient. They already understand all of that. It becomes a much more nuanced conversation. And as you guys know, so many of the things we do, they're complex.

It's not a one size fits all. It's important for patients to understand that's kind of the the danger of doing your own research, especially if you don't know where you're getting your information from. You have people posting online about, they did this protocol and they had this outcome and this was a miracle drug, things like that. That's where you have to be very careful because again, every situation is different and you really need the physician to help guide you as to what makes sense and what doesn't. Naturally, patient comes to me having done their own research, some of what they read and understand is true and I ⁓ 100 percent agree with and some of it is not quite as they believe. That's where we then spend our time discussing, pulling out the fallacies there, but explaining why that might be the case. I feel like right now patients are always coming in with a laundry list of different supplements that they're taking, And that's such a common one. And what I try to explain in those cases is the data behind most of those supplements is poor at best.

And my biggest concern always is if we don't have evidence to show benefit, then there certainly could be a potential harm. And in some cases, we find that out too late that there's a potential harm there. With certain supplements, things are not always regulated in the same way that some of our prescription medications are. So I think patients have to be mindful of where they're getting those supplements. I read an article not too long ago about all of these big protein companies, and they found high levels of lead in the protein powder that people are just buying off the shelf, things like that that you wouldn't think of that could be in some of these supplements. So again, it's one example of many different conversations that we have. But at the end of the day, I think all the information that's out there for patients is fantastic because they are able to do a lot more research and educate themselves at a higher level before they even step foot in the clinic.

I think that allows them to advocate for themselves throughout their journey, which is so important.

Abby Eblen MD (31:07)

Does US Fertility have any ongoing clinical studies that patients could say, hey, I really want to be a part of this. What clinic would I need to go to? And if that's the case, is there a place, can they go to the US Fertility website to look those up or?

Phillip Romanski (31:20)

Yeah, absolutely. We have maybe eight or nine prospective studies that are ongoing or soon to be enrolling. And we list all of those on the US Fertility website, including the clinics that are serving as active trial sites. Some of these are phase three trials where the study involves an administration of different types of medications during the IVF cycle. One study getting back to where we first started looking at increasing usability is what we call the escalate study. But this is where patients have previously undergone IVF and they get a PGT result with lots of chromosomal abnormalities. Sometimes you see three, four, five or more chromosomes that are involved in some of these aneuploid results. And what we started to think about is, you don't really see those kinds of results in when patients have a miscarriage and we test the tissue. Usually we only see one or two chromosomes involved there. So that's sort of a ⁓ discrepancy. And that made us think, are these true abnormalities or perhaps are some of these, what are sometimes caused like chaotic results?

Or are these perhaps issues with the particular DNA amplification and the assay of that singular embryo? So in that study, we're enrolling patients who have those embryos to do a rebiopsy to then run the PGT again to see if indeed that might be a healthy usable embryo. And we have some early data from one of our partner clinics that shows that some of those embryos could actually be euploid, healthy embryos. So we're really excited for the outcomes of that particular study because before that, again, those embryos go into that group of too risky, too dangerous embryos that we wouldn't consider usable for transfer.

Abby Eblen MD (33:03)

Very good. Any other highlights you want us to mention about research at US Fertility or what you guys are doing in terms of patient care?

Phillip Romanski (33:11)

The only thing I'll mention is all of this work is, like I said at the beginning, done by our large research team, which is run by Kate Devine, who's an REI physician in Rockville, Maryland, and ⁓ just a wonderful researcher, incredibly smart and thoughtful, and she does a great job leading the department. But Cassie Roeca is another research director who's based out in Colorado.

Lead epidemiologist, Carrie Flanagan, a biostatistician, Jing Wu, and such a long list of other physicians that are involved in the research. I'm just so grateful to be able to work with all of them, such smart people, and everything we do as a team is at the end of the day making big changes for our patients and the care that we're able to provide. We're just happy to be able to give back to the patients in that way.

Abby Eblen MD (34:00)

Yeah, it really seems like you guys have a really great situation with you. You have lots of really smart people that know a lot about basic science. They know a lot about clinical medicine and you have a huge database, which I think that's unparalleled probably by anybody else. So hopefully wonderful things are gonna come from this research over the coming years. Thanks so much for being with us, Phillip, and we appreciate it. And we look forward to seeing all the great things that US Fertility does and to our audience.

Phillip Romanski (34:18)

Absolutely.

Abby Eblen MD (34:26)

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Carrie Bedient MD (34:37)

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Susan Hudson MD (34:52)

As always, this podcast is intended for entertainment and is not a substitute for medical advice from your own physician. Subscribe, sign up for emails, and we'll talk to you soon. Bye!

Phillip Romanski (35:01)

Bye bye.