DISCLAIMER: Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser.
What does it take to grow a third party IVF Program?
Dr. Daniel Shapiro and Dr. Monica Best from RBA Atlanta provide exclusive insights into the intricacies involved in establishing and developing a third-party IVF Program.
Tune in to learn:
The essentials to staying compliant with the FDA
How to properly counsel patients on 3rd party options: Dr. Best’s tips
What to tell donors during the application process (And what to tell them if they’re not selected)
Processes currently impeding more 3rd party IVF cases (But how new technologies are changing that)
Dr. Shapiro’s hard-won lessons from running an egg bank
Dr. Daniel Shapiro
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Dr. Monica Best
Reproductive Endocrinologist
Reproductive Biology Associates
Website
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Instagram
Transcript
[00:00:00] Dr. David Shapiro: The barrier to egg donation is the supply of egg donors. If, if you build it, they will come, you know, there's between 18 and 25, 000 egg donation cycles a year in the U S and the demand is far greater than that. And so with the limiting factor right now is the availability of donors. And so anything we could do sociologically, technically, medically, financially, to make donation appealing to young women and safe, um, at the same time. Yeah, that would, that would grease the wheel on the egg donor side.
[00:00:36] Sponsor: This episode was brought to you by Mind360. A leading fertility mental health platform. How long does it take your clinic to get patients through their third party psycho psychological evaluation?
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Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser.
The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser.
[00:01:27] Griffin Jones: What does it take to grow your third party IVF program? What do you have to do to be compliant with the FDA? What qualities does your staff have to have? What do you need to say to the patient as they're being counseled on third party IVF options? What do you need to say to donors upon application? And what do you tell them if they're not selected?
And how? What are the process and technological impediments preventing more third party IVF cases from being done. And how is technology being used to remove those impediments? Technology that's on its way and brand new technology that's already being vetted and implemented by my guests. My guests are Drs.
Monica Best and Danny Shapiro. They're both practicing RAIs at Reproductive Biology Associates. who you know is RBA Atlanta. Dr. Shapiro is their medical director, and he's the clinical manager and co founder of an egg bank that you know pretty well. And we talk about the hard lessons learned from that and the mechanics behind building an egg bank of that size.
Dr. Best finished her fellowship in 2013, stayed in Atlanta, joined RBA. And for me, it was fun to interview Two physicians who worked together but started their careers roughly two decades apart. I found it insightful because it made it easier for me to figure out milestones, and I'd be interested to hear where you track on that timeline as well.
I hope you enjoy this topic on growing a third party IVF program with Dr. Monica Best and Dr. Daniel Shapiro, Dr. Best Monica, Dr. Shapiro Danny, welcome to both of you to the Inside Reproductive Health Podcast.
[00:02:52] Dr. David Shapiro: Thanks for having us, Griffin.
[00:02:53] Dr. Monica Best: Thank you, Griffin. It's wonderful to be here.
[00:02:55] Griffin Jones: It's my pleasure. It's been a while since I've covered a topic on third party IVF.
I feel like I should be covering it more. Maybe it's just because I'm on a David Sable kick and Dr. Sable is just recognized in New York and he's constantly talking about the, Potential population for art services being much greater than what we're currently serving. And so I feel like, well, third party is a big piece of that.
Maybe that's part of the reason why I feel that we need to be digging into this a little bit deeper. And each of you are recognized for your expertise in third party IVF. But I'm not that familiar with with either of it. And so I would love for, uh, each of you just to share what your third party IVF practice interest in areas are and how you develop them, Monica.
[00:03:49] Dr. Monica Best: Well, I mean, I'm, I'm really interested in almost all facets of third party, you know, to include, you know, egg donation, surrogacy, you know, helping couples through their journey with, You know, really any facet of this process. You know, I enjoy in many ways like opening, you know, the eyes of my patients because oftentimes, you know, really most often they're not, you know, this isn't on their radar as something that they're going to need to build their families.
So, you know, I really enjoy all facets of, you know, this field of medicine, you know, and, and ushering couples through their journey to reach their goal of building their family, no matter how that looks.
[00:04:35] Dr. David Shapiro: My interest in third party reproduction is not quite as ancient as I am, but it's, it's old. We've been doing egg donation at RBA since 1992.
I joined the practice in 95. Our lab director, Peter Nagy, brought vitrification here when it was
And I'm the physician founder of MyEggBank North America and its medical director and also the medical director currently of RBA and with Peter and our then office manager and our nurse manager, we put together the egg bank and Helped to change the way third party's done because we brought in frozen egg donation as a routine technology The other part of it that really fascinates me.
I love egg donation, by the way Very few of us love it to be honest with you. It's not something that most reis say. Oh god I can't wait to do egg donation But it really, it really grabbed me because it's the solution to a very common problem, which is diminished ovarian reserve. Now, some patients with diminished ovarian reserve are going to get pregnant on their own.
Some are going to get pregnant with IVF using their own eggs. Some actually need another form of third party, they actually need surrogacy, even though they might have diminished reserve, they also have a uterine problem. But egg donation solves the diminished ovarian reserve problem by bypassing it. For some people, that's appropriate.
For others, it's not. But for a great many, it is. And aside from that, egg donation is the only technology available for gay male couples that wish to have children. And, you know, with gay people in the family and they're thinking about family building, you know, there's, there's a personal angle to this too, where, you know, everyone should have the right to child.
rear if they are so motivated and third party reproduction makes that possible. And so I'm real enthusiastic about that because it expands the definition of parenthood. It expands the definition of childbearing and it gives us something really fascinating and rewarding to do. I want
[00:06:35] Griffin Jones: to hear more about what led you to forming an egg bank now almost 20 years ago, but I'm curious, Monica, if you agree with Danny's assessment that very few REIs love egg donation.
[00:06:51] Dr. Monica Best: Yeah, I mean, I, I think, you know, it's, it's oftentimes a very difficult discussion you have to have with, with patients because of course everyone comes in, you know, at least, you know, aside from, you know, the, you know, the same sex male couple who understands very clearly that they need an egg donor and they need a surrogate.
I think most of our, you know, patients do come in anticipating. being able to get pregnant, you know, if, you know, especially even if they're using donor sperm, they're still expecting to be able to use their own eggs and carry the pregnancy. And so it's oftentimes a really difficult discussion to have.
But I think once you get beyond that and, you know, patients. understand the efficiency oftentimes of the process. You know, I think it can be very, very rewarding, you know, to help someone build their family in this way, because in many cases, they may not have otherwise been able to achieve their goal of becoming a parent, you know, just with the barriers that we may have had either with, like Danny said, diminished ovarian reserve or uterine factors that really, you know, you know, present a blockade for patients to be able to carry.
[00:08:07] Griffin Jones: Was that the reason you were thinking of Danny, the heaviness of the conversation, or was there other reasons that you think of the Ari Aiza?
[00:08:14] Dr. David Shapiro: That's a big one. And Monica's absolutely spot on with that. It's a very uncomfortable conversation when you're talking to a woman in her thirties with severe diminished ovarian reserve.
And they really expect it to just be able to get pregnant and carry and have the baby shower and the whole thing. And it's, it's a dream blowing up. And and interdigitating oneself into that and not not implying that I'm deficited because I carry a white chromosome but it's it's a little harder actually I think for Especially us old guys to talk to younger women about this loss because we don't, we don't have that experience personally ourselves where, I mean, again, I'm not meaning to berate my kind, but younger women who are in childbearing age, I think have a better understanding personally what that's like.
But the reason I think REIs don't like it is because it's labor intensive. to recruit egg donors, to get egg donors through an ovarian cycle, to be compliant with the FDA, to make sure that every single box is checked and that there is not a thing missed, requires an awful lot of attention. and a staff with OCD.
Because you really just can't miss anything. And though the FDA regulations are really not that difficult to follow, you do have to know them. And special situations occur all the time, where we have to make an eligibility determination about whether an egg can be used or not. And that's, that's all part of the day to day management of an egg donor program, and especially with a frozen donor egg program, which is what we founded, um, not only do you have to be compliant, but you have to consider different state regulations about quarantine.
Like New York, you have a, there's a six month quarantine on gametes. Now, it hasn't really been applied to eggs the way it has been to sperm, but technically, they're supposed to be quarantined in six months if they're collected in New York. I don't think anybody's doing that. But, but if you follow the truest letter of New York regulation, yeah.
So we also have to have tissue licenses in some states where others we don't, because we're selling eggs literally. across state lines. So the, the management and the ability to follow and problem solve and take yourself away from the regular day to day of REI, which is busy enough to administer an egg banking operation.
That's a lot. And even if it's a small donor program, it's a lot. The, the nuts and bolts of it aren't that much different than regular IVF, but the regulation and the management is three to five times more labor intensive than regular IVF. And I think that's why a lot of REIs would rather not have anything to do with it just takes too much time.
[00:11:08] Griffin Jones: I want to go through those boxes that need to be checked when we come back to talk about management and I'll, and I'll go to Monica when we do, but I don't want to lose the, the thought of you starting my, I guess that was in 2005, was it, is that when you said Yeah.
[00:11:24] Dr. David Shapiro: Well, sort of, not exactly.
So one of the pharma companies brought a study to us in end of 2005, beginning of 2006, involving the new freezing technique. So vitrification is rapid freezing. You literally by hand plunge whatever you're freezing into a vat of liquid nitrogen and it It doesn't technically freeze for those who like P Chem.
If there's no phase shift, it's still in liquid phase, but it's so cold it can't flow. Vitrification literally means turn to glass. For people who know the physical chemistry, glass is a liquid. If you've ever looked at the windows of a 1750s Revolutionary Era house on the Concord Trail, you'll see that the windows have ripples in them.
And that's because the glass is flowing. It's a liquid and it's following the direction of gravity. It just takes 250 years for it to go an inch, but it's a liquid. The vitrification process, there's no crystal formation. So ice, as you may know, forms a crystal when it When it forms from water and it expands, which is unusual among freezing things and little knives is what those crystals are.
And they kill the egg or the embryo from the inside out. If you don't get the water out, vitrification allows ultra dehydration. And then rapid cooling to the temperature of liquid nitrogen. And the beauty of that is that when you take it out of the freezer and you rehydrate properly, you get back what you put in, where the older technique, the slow freeze technique was automated.
That's its one advantage, but you didn't get all the water out. And the water was replaced with antifreeze rather than just completely evacuated. And so that led to lower survival rates, worse pregnancy rates, very inefficient, relatively speaking. So when the pharma company brought the study to us as the then medical director of the practice, the nurse manager and I sat down and we over selected our best donors and great recipient candidates to see what this would look like.
And we took 10 donors, we split their eggs, we froze them first, and then we distributed those eggs to 20 recipients. And 15 of the 20 were pregnant on the first embryo transfer. And there were 5 who had frozen embryos from those frozen eggs, and this had never been done before. where frozen eggs were turned into frozen embryos and then made babies.
And we had two of those five. And we were sitting at a meeting after the first nine cases had been completed and there were seven pregnancies. And I looked at our lab director, who is still our lab director, Dr. Naj, Peter Naj, and I said, I think we just became an egg bank. Now, there was some resistance in that moment.
That was at the very end of 2006, beginning of 2007. There was some resistance because it was a newer technology and we didn't want to stick our necks out too far and then have our heads cut off because we made a mistake. But we had enough proof of concept that we were able to organize a bank relatively quickly.
And so I sat down with a handful of selected nurses. Some of the best nurses in the practice at the time. And we established criteria for donor selection. We established criteria for donor management. We established criteria for posting of eggs. We started our rudimentary website to make the eggs available to recipients who wanted to review the frozen donors.
And by the end of 2007, we'd done about 30, 40 cases. And then in 2008. We just went hog wild and we did a hundred and something, and then in 2009 we did like 180, and then in 2010 we did over 200, and then we went national in 2011 and we invited other practices to join us and we shared the technology. So that they could make eggs at the same time we were and then we developed a network of egg banks basically that share eggs Share the technology and we like embryos can be made in Seattle and shipped to Atlanta to for an Atlanta recipient eggs can be shipped from Las Vegas to Boston where they can make the embryos in Boston.
We can do PGT in some of these cases. And so we created a commerce really over, over biologicals that previously had not existed. And the end result.
[00:15:45] Griffin Jones: So you're among the first, you're, you're establishing this and I, and I want to hear more about that. And result. But as you, as you're training, Monica, as you're training in fellowship, as you're coming into the field, how much of this is established versus how, uh, versus how much of it was all already established or still needed to be established?
[00:16:05] Dr. Monica Best: Yeah. So I, I started at RBA my career in 2013. And so I am walking in to this very. Rich history and, you know, just the richness of something that, you know, I previously, you know, did not have a lot of access to in training, you know, at Emory, um, where I did my fellowship. So, you know, there was a very steep learning curve here.
for me, but I think, you know, I just was tickled by the fact that we had the availability of this resource so that I could help my patients. You know, I did not have very much exposure to this. Before I started at RBA and so, you know, as Danny was saying, you know, it was just starting to explode At the time when I started practicing and so, you know, I you know as they say, you know You stand on the heels of Giants and you don't even realize you are and it seems like you know, oh well Of course, we have, you know, egg donation.
Of course, we have this network. But, you know, it, it just, you know, I tell patients all the time, like, what a great day in age to be practicing because I have every resource at my disposal and I know that I can help you get there. It's just a matter of, are you open to all of the options?
[00:17:34] Griffin Jones: And so was this, was your first job at RBA?
Was that your first job out of fellowship? Yes. So you're in fellowship, presumably like 2010 to 2013, somewhere around there. Yes. And during that time, are you learning about egg banks forming and how they work and, and gestational care agencies and how they work or are you just learning about the medicine but not necessarily how it all, how you actually get those gametes, how you get those gestational carriers?
[00:18:02] Dr. Monica Best: Right. I think I had very limited understanding of egg donation in an egg bank. When I started in 2013, of course, you know, I understood surrogacy and, and I understood, you know, things like sperm donation, you know, anonymous sperm donation in patients that I treated, but really knew very little about, you know, egg donation and just, you know, what a, what a game changer it could be for my patients.
in terms of the availability of it. So, definitely was eye opening when I started.
[00:18:36] Griffin Jones: How is it, how important is it for doctors to know the mechanics of how an egg bank works, how a GC agency works, how, like, is, it, it, it, like, is it really important? Is it somewhat important or not very?
[00:18:49] Dr. David Shapiro: Hard to answer my bias is that it's medium important.
Okay, the nuts and bolts. Nah, no one's got time for that and they don't need to but to just say, oh, it's an egg bank. I'm just going to send my patient there. It's better to understand. I think sort of the. the gestalt of, of how a donor winds up being a frozen egg donor. Some of the egg banks, they take donors and dedicate them just to egg freezing, which is mostly what we do in the frozen side.
Others will use eggs not claimed in a fresh cycle. As the leftovers so to speak as their egg bank eggs, they'll freeze the leftovers The one's not inseminated for the benefit of the original recipient when you do it that way when it's when the bias is toward freezing the leftovers for People to come and take what's on the you know, filings basement shelf, the pregnancy rates are lower.
When you dedicate donors specifically to a frozen program, you get pregnancy rates pretty darn close if not the same as the fresh transfers, even without the genetic testing of the embryos. So. Knowing what model the bank uses, I think the physician should know that because if they're sending their patient to egg bank X, they want to know that the frozen eggs available to that, to their recipient are going to be eggs that were dedicated to that.
Purpose, because that's going to give the highest yield, where they could send to egg bank Y and be getting the eggs that were the last state of the 27 that were collected, and the lab, through insensible means, assigned the first 19 to the fresh cycle or whatever. And the eggs that they didn't like quite as much, but wouldn't say that, actually are the ones that wind up frozen.
You know the negative selection bias when you split the eggs fresh and frozen on purpose Winds up deficiting the frozen I think in fact, I think there's some evidence to that And so we do that too here. We the leftover situation, but the the primary Goal is to find a donor who should be all froze, frozen, so that you get the best eggs from the cohort in the freezer.
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[00:22:42] Griffin Jones: Monica, you're coming in. This infrastructure is established and you said you're standing on the shoulders of giants, but giants don't, fig, aren't, don't, aren't able to figure everything out and none of us are over. Even giants. Just saying.
And, and, yeah, and, and, and you're never tall enough to have everything figured out. And so what did you have to still figure out when, as you started getting into practicing third party IVF? Monica.
[00:23:10] Dr. Monica Best: Yeah. I mean, I think, you know, just the logistics, like Danny alluded to earlier, you know, just the attention to detail and, you know, helping patients to sort of understand why we do what we do, that things have to be done a certain way, and we have to be compliant with the FDA.
I think one of the things I do is kind of walk patients through, you know, this is, you know, the process by which we select our egg donors, I think is important for every physician to understand so that they can relay that information to the patient just because that is important for them to know. But, you know, you know, they're, they're even, even if, you know, again, we're the most well oiled machine around, still as a clinician, I was, you know, having to You know, interface with the nurses who were expert in the FDA and understanding almost always there's an exception.
Almost always there's a special situation that comes up or tends to come up at RBA just because the complexity of our patients. And so, you know, having to go back, even though there are well defined guidelines of what the FDA requires, okay, well now we have this exception or now we have this complexity, you know, how do we either.
You know, you know, do something to make it compliant, or is this a case or, you know, a scenario that we can't accept moving forward? And there unfortunately have been those cases.
[00:24:42] Dr. David Shapiro: Third party is as much getting all of the pieces of the puzzle organized properly as it is the science, the reproductive science.
[00:24:52] Griffin Jones: Let's talk about a couple of those. Those puzzle pieces for each of you to walk us through it. You said, you know, everything has to be all the boxes have to be checked. What are those boxes going going as chronologically as you can?
[00:25:09] Dr. David Shapiro: Well, all right. So if you're, if your goal is safety for the donor, respect for the donor recognition for the donor's autonomy, and at the same time getting good eggs so that you get the pregnancies at the expected rate, you should limit it.
The age 21 to 31 should not take donors over 31 years of age. They should be able to fill out the questionnaire that we developed without triggering any of the hard stop questions that get them excluded. And they don't know which ones those are. They need to, we used to require that people be free of genetic carrier states.
But with 550 plus diseases on the panel, everybody carries something. So now we, we make sure there's no infortuitous match, but we do allow donors to carry pretty much everything except for X linked and obviously dominant diseases. The, the exclusions are numerous and you have to know what they are. I mean, they're, you can't even have a relative.
One relative who had heart disease before 50. One first degree relative, you're excluded. You can't have two relatives with diabetes. You're excluded, right? You can't be on psychotropic medication at the time of your donation. You're excluded. And the donors don't know this. And when they're filling out these questionnaires and we're vetting them, this is what we're looking for.
What are the exclusions? What are the exclusions? If they get through the questionnaire, then we assess their genetics by blood testing and genetic counseling. Then they go for basal antral follicle count and anti mullerian hormone level to make sure they're going to make enough eggs. Because if they're not going to make enough eggs, it isn't worth their time and it isn't worth it to us, quite honestly.
And so we, we bias heavily in terms of excessive ovarian response, which we can do safely now, which is one of the other big innovations in reproductive medicine in the last 10 years is the ability to get tons of eggs without hyperstimulating the patient. That's really what makes egg banking possible.
Something called agonist trigger, which replaced the old technique, which was called HCG trigger, which caused hyperstimulation and hospitalized donors all the time. It was a fraught technology, but with agonist trigger and a little bit of moderation, you can do this safely. The average egg yields within the egg banking.
practices that we're contracted with is 26 per retrieval, which is a very high number, right? But if each egg lot is six eggs, you get four egg lots out of every retrieval, which is the goal, right? And so we can do that safely. So we screen for very high ovarian response. We then have them come in for infectious disease testing because the FDA requires it.
They also, the timing of the testing is critical too. You have to get the egg donor, has to have her FDA infectious panel done within 30 days of the egg collection, otherwise the eggs are invalid, can't use them, right? So we typically draw the blood when they start their cycles, because that way we'll have it within 30 days.
But they also have to go through psych testing before they even begin a cycle. And they either do something called a personality assessment inventory or an MMPI 2, Minnesota Multiphase of Personality Inventory. We require that our egg banking network requires that PhDs administer the test because they're the only ones with enough training to actually score the tests themselves.
So that's the, the MyEggBank standard, which is the name of our egg banking operation. We use the PhD standard because. We think it should be the standard of care. The idea that you can test somebody to make sure they're psychologically stable and then send out the test to someone who has not interacted with the donor and have the test scored and be valid?
Too much risk. We won't do it. So we, we, it has to be a PhD level to screen our donors. Otherwise, no. We won't accept the screening. If they've been screened elsewhere and it was not by a PhD, we make them redo it. Once that's all done, the infectious disease testing, the full exam, the full interview, the psych, the ovarian reserve screening, the genetic screening, and of course the questionnaire, then they can go through ovarian stimulation.
And then there's a, a kind of a rote thing that I've noticed this just because I'm an old guy. The younger generation that's training now, they've learned ovarian stimulation kind of on, you know, like Betty Crocker, like Betty Crocker recipes. My generation was the first generation to benefit from the founder generation.
Working all of this out, but part of my training was I had to learn the basic physiology of each one of these drugs and why you pick one over the other. What we've, what we've learned in the last, well now 15 years of regular egg banking is that not every donor should be stimulated the same way. That there are combinations of drugs that are more favorable in some situations and less favorable in others.
And you have to be flexible in how you write the stimulations. There's a concept in reproductive medicine right now that everyone has to be on something called a combination protocol. It actually goes against the science. And the people in my generation were trained on that difference. My generation knows there's a difference between what's called an FSH only protocol and the combination protocol.
Now certainly there's a role for combination protocols, there's a big role for them, but it's not 85 percent of the protocol. It shouldn't be. The, the more basic protocol, the FSH only version actually is preferable in most cases. But that's not what people are taught now, even though the science says that that's true.
So part of the management of all of this is understanding what pieces you can manipulate to get the optimal outcome. So somebody with a lot of experience in ovarian stimulation or somebody who can teach others about ovarian stimulation, that's a critical component to this too.
[00:31:05] Griffin Jones: So you're talking about change and innovation, which is a theme that I want to dig into a little bit more, because I Have this feeling that if you were to just sum up just if someone from outside of the field that knew nothing about art had to just kind of listen to people's feedback and then summarize in a sentence or two the level of change that's happened in the field that From all of the voices, they would surmise that nothing has changed and everything has changed.
And I suspect that there might be some of that flavor in third party as well. So before we go all the way back to 2013. What has changed in third party IVF since you've been practicing, Monica?
[00:31:50] Dr. Monica Best: Oh gosh, you know, I mean, I just, I think the just sheer availability of eggs from multiple egg banks and just having to sort of manage that with patient expectation, you know, just coming from, you know, the perspective of RBA and our egg bank.
And, you know, having some level of control of the information about donors and understanding kind of the efficiency of our program and then having to sort of manage patient care with respect to them, you know, acquiring eggs from other egg banks, you know, just, you know, having to kind of, you know, deal with those differences I think is, has been something that's changed for me because.
You know, when I first started, I mean, it was, it was our egg bank. I mean, that's, you know, we were the largest egg bank in the country, the first egg bank in the country. Again, there's a lot of control and there's a lot of management of efficiency there. So I think that's one thing that's, that's, that's sort of changed.
And I also think, you know, patients. understand more about egg donation than they did when I first started. So I think that's helpful in counseling patients.
[00:33:06] Griffin Jones: What makes you say that Monica, what kinds of questions are they asking you now that maybe they weren't 10 years ago?
[00:33:12] Dr. Monica Best: You know, I mean, I, I think, you know, they're, they're asking about the availability of you know, of the resource.
You know, I don't necessarily have to, you know, counsel each patient that, you know, that egg donation is their most efficient path. Many of them come in understanding that or understanding that they need surrogacy. And so that, that does make the conversation easier. That does kind of help with efficiency of getting them.
from point A to point B. So those things have changed, I think, in the sense that, you know, we, we do have more resources, but in some ways it does make it more difficult because it's just, I mean, it's hard to find the same efficiency with other egg banks and other kind of, you know, third party entities that we have.
[00:34:01] Dr. David Shapiro: I, I think, I think there's also been a cultural shift among physicians on this. When I started here, without naming any names, there were physicians in our group who were flatly opposed to taking care of same sex couples, men or women, wouldn't. And that's going to be the bulk of third party in years to come.
And now it's every day. Everyday. And what, you know, might have raised the eyebrows of a baby boomer 25 years ago makes a Gen Y, Gen X, or millennia, or millennial, whatever you call them, go, yeah, and, I understand, right? This is what you do. Why are you even hesitating? Right? So there's that shift. Patients have come to expect also that this is something that they can access easily because they see famous people using egg donors and surrogates.
So it's out in the common, it's out in common parlance. People talk about this like it's nothing. Janet Jackson having a baby at 50. You don't have to be a rocket scientist to figure out how that happened. Right. Or Gina Davis at 48 to figure out how that happened.
[00:35:17] Griffin Jones: But do you have a lot of not rocket scientists coming in because they, they have not figured it out?
Because I hear that from doctors as well, that people have an inflated expectation of what they can do with, you know, just their own eggs.
[00:35:31] Dr. David Shapiro: Because when the desperate housewife, I forget her name, the redhead, she went. She had twins with egg donation. She was very public about it when it happened. She said, this is egg donor.
Don't be ridiculous. I was 44. That's what she said. And that I remember when that happened, because I remember the patients and the reaction in the months that followed that revelation after her twins were born, people were like, it's all egg donor, isn't it? Like, so, I mean, all of these. Trade mags and the globe and, and national inquire with babies at 52.
I mean, it's not like donor, right? Like, like, yeah, we, we watched the interview with what's your name? And yeah. Yeah, we get it now. Now that hadn't happened in a while, but yeah. But they hear it. They know. More and more.
[00:36:24] Dr. Monica Best: Patient expectations, I think, is helpful, right? Um, you know, those difficult conversations we were talking about before sometimes aren't as difficult when patients You know, when their expectations are, hey, I'm 44.
I know what I need. Or, you know, just like Danny was saying, you know, I think the ability to be able to treat same sex couples is extremely rewarding. You know, they, they come in, they understand what they need. And again, we have the resources to get them there. So, I mean, that's, that has shifted and grown and morphed really since I started practicing in 2013.
[00:37:04] Griffin Jones: Are there instances where expectations go the other way? So there's, there's a higher education on the part of patients, but does that ever put them in a place where they know enough to be dangerous now?
[00:37:19] Dr. David Shapiro: You want to take that one?
[00:37:22] Dr. Monica Best: Absolutely. You know, I think I, you know, I spend an inordinate amount of time you know, trying to manage expectations.
I think even under the best circumstances, there's still a failure rate of 30 to 40 percent. You know, embryos don't implant 30 to 40 percent of the time. Miscarriages still occur, even if we know we're dealing with genetically normal embryos, this gold standard. So I think, you know, yes. Yes, there are sometimes unrealistic expectations.
And some of these are emotional, right? You know, you're, you're spending all of this time and, you know, your, your resources in terms of, you know, your finances, your physical resources, everything. And you expect that after you You know, invest all of that, that you're going to be pregnant and, and I think sometimes those are, those are the difficult places to be.
[00:38:15] Griffin Jones: So , you started talking about the, the different requirements for donors from, it has to be done by a PhD, the, the hard stop questions, the exclusions, what were some of the hard lessons that you learned in the last, whatever it is, 16, 17 years regarding those?
[00:38:39] Dr. David Shapiro: Some, some of the donor candidates with good reason.
I mean, I understand this. They take it personally when they're, when they're excluded. Right. It's yeah, they came because they were going to be compensated. There's no question that money makes the difference when there's no compensation for donors. There is no donation. That's very well established. And though they may come for the money.
They're personally invested in it because they realize they're doing something altruistic. And when they're informed that for any number of reasons they can't, some of them take it personally. And so we've had to modify how we handle notification of the exclusions. We used to do it, it was automated when they were filling out the questionnaire, if they tripped one of the booby traps.
They'd get an email saying we can't screen any further and that was it. And that was, that was chaotic because it created a lot of phone calls of angry donor candidates saying, why would you do that to me? I want to give my eggs. There's nothing wrong with me. And there may not be anything wrong with them technically, but there's something on the FDA thing that's excluding them or there's something on the questionnaire that's excluding them.
And there's no way around it. We used to, when they were excluded on psych, we used to be the ones to inform them, now the psychologists inform them, when they're excluded based on psych. Because it's not that they're crazy, it's that somewhere on one of the scales where they got assessed, the risk is to them, not actually to the baby.
That going through the process and knowing that you have donor derived offspring out there without being able to know who they are, for some people, that's a little bit psychologically taxing. They should not be donating. And it comes out in the screening. And so the, the way the psychologists now will say to them is, look, there's nothing wrong with you, but here's what got tripped on the testing and this is the reason for the exclusion.
So it's not personal. It's just based on nuts and bolts, what, what can we can allow according to the care standards from our professional organization. It ain't about you personally. And that's been, that's turned out to be way better than having us make the. Notifications that they're excluded. So we learned that.
Um, we also learned that if you tell the truth really starkly about what to expect in terms of pregnancy rate per embryo transfer, people hear it, they hear it right. Yeah, this works great. And the cumulative pregnancy rates, meaning with multiple transfers, there's 85 to 95 percent live birth rates in most donor programs, right over time, but not per transfer.
And so in the course of the conversation, you have to talk to patients about, we learned this along the way. You have to talk to them about the cumulative rates. You have to talk to them about what multiple transfers look like before they reach their goal. You have to. Set expectations, as Monica was saying, and Monica is very good at interacting with her patients.
She's being a little modest by describing the emotional piece, but her patients love her and they get a lot from her over the emotional piece in third party. And that's a very important thing to tend to. If you make it too science, science, science, people kind of glaze over a little bit because in the end, they're talking about their baby.
Right. And they're, you're trying to, you can't science size their babies. And so, you know, the emotional connection, the ability to show somebody that even if you're not feeling what they're feeling, you understand it.
[00:42:03] Griffin Jones: So I've made a note because I want to ask Monica about that, that counseling. But what you're describing, I would never equate a gamete donor with a job applicant.
Donating gametes isn't applying for a job, but there are parallels. And one of the th One of the things that I would love to be able to do with people that apply for jobs at my company is tell them the reason why I'm not moving them forward. But every HR professional will say, No, you don't do that. You just tell them you just you just give them the thank you and stay, please stay involved and keep us consider us in the future.
And so what to what degree are you informing them of why they weren't selected?
[00:42:45] Dr. David Shapiro: The donors, when they're not selected, they all get told why.
[00:42:50] Griffin Jones: They'll get told why. They're told the very specific reason why, or is it kind of, is it a general
[00:42:55] Dr. David Shapiro: It's going to be a lab test. It's even, so this is the other thing people don't realize.
If you run the FDA panel, and even though the patient, the donor, does not have HIV or hepatitis, a false positive test, even if you can later prove they really don't have the disease, They're excluded. You can't go back and say, Oh, no, that was wrong. And then use the donor. And so you have to tell the donor why she was excluded based on a false positive, because what's she going to do?
She's going to go to the next program down the road and they'll retest her and pretend like she wasn't tested before when she was already excluded. And so, you know, you have to have the paper trail. There is no donor registry. There should be because people who do that should not be approved in another program after they've been properly excluded in the first.
But because there's no registry, we can't keep track of that. So if you say to a donor, Hey, the psych came back with an invalid score, but you're not crazy. There's nothing wrong with you. You're highly functional. Don't worry about it. But this is why The booby trap got tripped then either they're going to take the appropriate amount of time which on the psych is two years And you know wait until they can be retested because they've been told you know, you shouldn't be applying again for two years So we've done our due diligence by telling them the reason We're, we've taken responsibility for saying to a donor, look, you got excluded and by rights, you should always be excluded on some of the testing, or you should be excluded on the site for two years, but it's not permanent.
And then that gives them a framework. And then we can document why we excluded. And if anyone ever comes back and asks for our records, they can see exactly what we did and that we properly counseled the donor so that we're still compliant with FDA. We're still compliant with best practices and.
American Society for Reproductive Medicine guidelines. And we're doing the right thing for future recipients because some of these exclusions actually do protect the recipient, though most protect the donor. So, we have to tell them. They have to know why.
[00:45:04] Griffin Jones: Wish we could do that for jobs. Monica, I want to ask you about the counseling prior to treatment when you're counseling a patient on third party options because I noticed some years back that The physician's approach is probably one of the is probably the single biggest variable on determining if they move forward with treatment, provided that, you know, cost isn't a barrier and that sort of thing.
And we really researched it for a while. And I could tell that there is one end of the spectrum. This is just kind of this isn't third party. This is talking about more generally IVF. But there's one end of the spectrum where you can be too prescriptive and the patient feels like they're being pushed into IVF and they or they and they feel like they're not being listened to.
But there is also another end of the spectrum, which I think is easier to err on, actually, where the patient feels like they're getting too many options and they. It's like I'm coming to you the expert and I don't know what I'm supposed to do after this. And I found that the, the, the docs that are, are more prescriptive, as long as they're, they don't go too far, tend to, to, to resonate more with the patients.
Although there's, there's a number of different personality variables, but what is your approach to counseling on third party? What do you find to be?
[00:46:26] Dr. Monica Best: Um, Yeah, I mean, I think I think of this really from, you know, an efficiency standpoint, and I try to get the patient to see it from that perspective. You know, I have.
A large volume of patients in my practice who are, you know, advanced age and, you know, again, never thought that they would be able to, or never thought that they would get pregnant any other way besides utilizing their own eggs. And, you know, I have to get them to understand that not just RBA, not just Dr.
Best, not just the clinic down the street, but nationally in the world. You know, the limitations to being able to utilize your eggs are going to yield a likely zero percent chance of success. And, and so, you know, we give our patients lots of autonomy at RBA. You know, we, you know, we of course just recently established an age cutoff.
And so we give patients. a lot of autonomy to proceed with IVF with their own eggs. But I think what I do is I really spend a lot of time talking about how, yes, we could do four or five cycles and still not get there. Or we can shift our resources to doing something that's actually going to get them a baby.
And, and potentially multiple siblings from that one cycle. And so, it's oftentimes not just one discussion, it's oftentimes not just one consultation, but it may be, you know, two or three. Again, just. You know, kind of going back to what Danny and I were talking about earlier in that, you know, yes, there are a lot of physicians that don't like doing this and that's why, you know, again, you know, you plant the seed and it's something they never conceived of and then they come, they marinate on it, they come back and you're like, listen, If these are the resources we have to work with, if we really want a baby, then this is the direction that we need to really be, be moving in.
And, and so it's, it's, a lot goes into those discussions and just meeting the patient where they are. You know, some people need data, some people need for you to, you know, just speak to them woman to woman. And, you know, I oftentimes will say, look, I've had my own struggles with infertility and I've been in your shoes before and I understand, you know, kind of what the emotional piece of this is.
And, and oftentimes you'll, you know, you know, some patients may still cycle a couple times and then you just still keep bringing it back home. Okay, so this is what we had, you know, I have a 45 year old recently who, you know, Had like six blast biopsy at each cycle and everything's abnormal. And of course, you know, I said we, we would have to do an inordinate number of cycles and you just don't even have the time left to be able to do that and still be efficient.
[00:49:45] Dr. David Shapiro: If, if I may, there's, there's another part of the counseling that I lucked into by accident. It just sort of flew out of my mouth one day and it turned out to be one of my stock statements because it worked and it's true. Which is that DN That's half
[00:49:58] Griffin Jones: of my sales pieces, by the way, Danny, half of, half of my sales scripts are from just, Oh, that worked that one time, somebody that's, the light bulb went off.
I should use that one again. But yours are DNA
[00:50:11] Dr. David Shapiro: might be destiny, but it isn't parenthood. Right. And so what we're getting to with egg donation, and same with third party surrogacy with people carrying, um, a baby's a human being that's going to have its own soul that it's naturally wired for, but that is influenced by the people who raised it.
And, yeah, the DNA may Direct the behavior in one way or the other, and intelligence may vary a little bit. But in the end, the parental influence is the bottom line. And the experience of carrying a baby, even if it isn't your DNA, it's your baby, right? By everyone's definition, except the genetic one. You deliver the baby, you experience pregnancy, you experience the, the aches and the pains and the terror with, uh, contraction at 22 weeks, all of that makes you a mom.
And so when women start, and again, this is an old man having this conversation, but when I introduced that concept, I see younger women's eyes kind of go, Oh yeah, right. And it opens the door. It doesn't always get them through. But it opens the door, they may
[00:51:28] Dr. Monica Best: need another consult to hear it again, you know, or more or more and I think to, you know, as couples go through this process and I'm just speaking of like kind of just, you know, your routine, you know, couple where the woman has diminished of Aaron reserve and, you know, you're going to use the partner sperm.
I mean, that's. That's, that's a huge advantage because patients are like, okay, well, what about adoption? What about this? Or what about that? And just kind of going back to what Dani was saying, you know, just being able to tell patients, you know, you have the opportunity to experience pregnancy. Your partner has a genetic link.
Even though you don't have that same genetic link, your, your genes and your body are influencing the expression of those genes. And it's a, it's powerful. It's really, really powerful to patients. And, you know, again, they see that, that advantage. And I think just from an efficiency standpoint financially, it's just as efficient, if not more efficient than adoption in many ways.
And you get this added benefit of being able to carry and potentially your partner having a genetic link, if that's It's the scenario, you know, and so it's just, it is, it is extremely rewarding. And I tell patients, I've never had a patient who pursued egg donation who regretted it when they saw
[00:52:55] Dr. David Shapiro: absolutely 100 percent agree with that.
[00:52:58] Griffin Jones: There's no way to, yeah, there's absolutely no way to.
[00:53:01] Dr. David Shapiro: That's right. I, and I won't, and I've never seen it either and I've been doing it longer and I'm going to retire in the next 10 years and I won't see it before then either. Yeah. So I
[00:53:10] Griffin Jones: think I want to conclude with what you see as the roadblocks that can and should be removed, converting and, and, and, and for the providing third party IVF treatment for those that need it outside of the payer stuff.
So don't not, not coverage and let's, let's pretend that that's solved for or will be solved for. Let's pretend that for this conversation and as specifically as you can think, what are the technological or process impediments if, if, but for those, uh, we would be seeing a lot more third party IVF patients.
[00:53:48] Dr. David Shapiro: Depends if you're talking about surrogacy or egg donation. Either. Your pick. The barrier to egg donation is the supply of egg donors. If, if you build it, they will come. You know, there's between 18 and 25, 000 egg donation cycles a year in the U. S. And the demand is far greater than that. And so the limiting factor right now is the availability of donors.
And so anything we could do sociologically, technically, medically, financially, to make donation appealing to young women and safe, um, at the same time. Yeah, that would, that would grease the wheel on the egg donor side. Surrogacy is a little different though. That's, I think that's a social, a socialization process is going to take a while.
Because, you know, right now most surrogates are paid. And surrogacy is the kind of thing a sister can do, a best friend can do for you. The more sociologically this becomes. De rigueur, actually, the more I think people will be showing up with friends and siblings and not paying the agents and not paying surrogates for hire.
That's going to take a long time, but that's, in my opinion, a sociologic barrier that will eventually fall, but it's going to be a while.
[00:55:04] Griffin Jones: I've got to ask the AI question because it seems like every, no matter what subtopic of the fertility field we're talking about, there's some application for AI and often we're talking about it on the lab side.
Where do you see applications for AI in the next two or three years with regard to whether it's, whether it's donor selection or whether it's gamete grading or embryo grading or what are the applications you see for third party?
[00:55:33] Dr. David Shapiro: All of it. How close are we? We're there. It's the ultrasound that we demoed the other day has an AI function to make sure the follicular diameters are exact and reliable and reproducible.
And it's the first system we've seen that has an AI function in it to guarantee that what you're getting is a true representation of what's in the ovary. It's a quick, much quicker scan. It just right through the ovary, every follicle gets. Uh, counted almost instantaneously the exact shape, the location, an accurate number of follicles, right?
Ultrasonographers are human beings and they're real good, but sometimes they're under counts, sometimes they're over counts and that gets the patient expectation and what it's like in the retrieval suite if they think they're getting 30 eggs and only five come out, right? So AI and ultrasound is already there.
It'll be there in embryo grading. If it isn't already in some practices, I think there's a program that's been released already, but I haven't seen it. I think it's going to help us determine who's going to be a good responder and a not good responder, because AMH, though a very good tool, is not a perfect tool, right?
We're going to be, all the predictive modeling that goes into AI, is going to help reproductive endocrinologists know who should be a donor and who shouldn't, who should be a recipient and who shouldn't, who's likely to get pregnant and who's not. Right? And you can, you can show all of this to the patient and say, here's what the math is saying.
Here's what we can do to either bypass or trick the math, but here's what it says.
[00:57:14] Dr. Monica Best: Everything. Everything. It's going to be everything. Like I want to know, I want to know down to, I want AI to tell me down to which eggs we should be fertilizing and which sperm we should be picking up to do ICSI with. You know, or, you know, because I mean, I think, I mean, again, there's just so many applications to that, you know, women that are coming in and freezing their eggs, like, okay, well, we can't genetically test eggs, but is there some function?
I mean, again, that I would. You know, that would be right.
[00:57:44] Dr. David Shapiro: Is there something in the microscopy that I could recognize? Is there something in the stimulation in that you plug into an AI function and it tells you which set of eggs are going to work better within a cohort, right? Which egg is the one you should use first, right?
Yeah, all of that's coming.
[00:58:03] Griffin Jones: Dr. Monica Best, Dr. Danny Shapiro, thank you both for coming on, sharing your thoughts of what is happening now in third party IVF, what needs to come so that more third party IVF patients are able to be served. Thank you both for coming on the program.
[00:58:21] Dr. Monica Best: Thank you so much for having us.
[00:58:24] Sponsor: Guide your patients to Mind360 for immediate access to high quality psychological evaluations and fertility mental health tools. Don't delay your patient's cycle. Find out how quickly this process can be completed by downloading their free report at mind360.us/reducedwaittime.
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