How does intravaginal culture compare to IUI and IVF and who should consider this new fertility treatment? Our guest is Dr. John Park, a board certified Reproductive Endocrinologist with Carolina Conceptions.
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How does intravaginal culture compare to IUI and IVF and who should consider this new fertility treatment? Our guest is Dr. John Park, a board certified Reproductive Endocrinologist with Carolina Conceptions.
Please leave us a rating or review RateThisPodcast.com/creatingafamily
* Note that this is an automatic transcription, please forgive the errors.
Speaker 2:Today we're going to be talking about intra vaginal culture with Dr. John Park. He is a board certified reproductive endocrinologist with Carolina conceptions in Raleigh, North Carolina. In addition to being an RV, he has also earned a master's of science and clinical research. Welcome Dr. Park to creating a family. Thank you. Thank you for having me. Yeah, I was particularly interested in your, a master's of science and clinical research. We are a research geeks around here at creating a family. We try to be the bridge between the research community and the patient and nurse community. So anyway, when I saw that my eyes, I had to of course to include that in your introduction.
Speaker 3:I appreciate that. We try to practice a evidence based medicine as much as we can and uh, going through that, uh, extra bit of education certainly has made me be more critical of the information that's out there.
Speaker 2:You know, that's such an interesting point. Yeah. I, uh, I would think that is exactly true or right in order to understand who should consider intra-vaginal culture. Let's go through kind of the basics of what we recommend for people trying to conceive. And again, the basic advice which most of our listeners have heard more than once, is that if you are under 35, you should try for one year with timed intercourse before you see a specialist. Unless, let's be honest, unless there are other reasons you have to anticipate that you might be having, uh, uh, fertility problems if you are 35 or older, you should seek treatment with a specialist sooner and generally no later than six months. So what we're really talking about is options available to people at this point. Um, is that, is that pretty much the lay of the land? Uh, Dr. Park?
Speaker 3:Correct. Um, those recommendations are in place by the American Society for Reproductive Medicine and um, those, those are good recommendations to go by.
Speaker 2:Okay. So, uh, what are, uh, patients, somebody who has, has been trying for a year with timed intercourse, uh, and time did of course, of course means making certain that you are having sex during the time that you are ovulating your most fertile times. So for those people who have been trying for the requisite period of time, what are their options for fertility treatment? And let's go with, start with kind of at the, at the, the more simple and then move up.
Speaker 3:Sure. If a patient or a couple has gone through the evaluation and there hasn't been an obvious cause of their infertility, then in most cases patients start with oral medication for a Varian stimulation. And the most common types would be Clomid or letrozole. And when those medications are used, um, they can help the patient control the timing of, so the couple can be more precise about timing intercourse. Um, but they could also use those oral medications in conjunction with IUI.
Speaker 2:Okay. And IUI for four, again, I think most of our audience knows this, but is intrauterine insemination.
Speaker 3:If a few months of treatment with oral medication has failed, then the efficiency of the process can be increased by getting the patient to[inaudible] with more eggs. Um, and that would involve taking injectable gonadotropins. More monitoring would be required with that form of treatment to make sure that, uh, we're getting the desired effect out of the ovaries, but at the same time, not too many eggs will be released so that we can minimize the chance of a multiple pregnancy. So that requires a more monitoring and there's more of a balancing act in that form of treatment. But the idea is to control when the patient ovulates. Um, and uh, but just with more eggs than we can get with oral medication. Um, and then again, the patient can try to get pregnant through either time to intercourse or IUI.
Speaker 2:Okay. So, uh, so that's kind of the second tier and we should mention that these don't necessarily have to be tiered, uh, that depending on what your diagnosis is, are and what your doctor is saying, some of these would make sense not to do it all or to do them for longer or in a different order or whatever. But generally speaking, you're kind of working this up. The fertility treatment ladder. Okay. So we, uh, let's assume that I, you eyes have not been effective, uh, or what, what's the next thing that you might consider?
Speaker 3:Well, the next thing traditionally has been to move on to regular conventional in vitro fertilization or IVF where the patient uses the injectable gonadotropins to stimulate a much larger number or cohort of eggs to develop. And rather than oblating, the patient will undergo a procedure to extract the eggs, the egg retrieval procedure. And then in the laboratory those eggs could be fertilized by literally injecting a individual squirm into those eggs. And by having a larger number of eggs, we can, we hope that, uh, we have several embryos that develop well over the next five days and then usually only one embryo is then returned to the uterus. Um, in the embryo transfer procedure. If, uh, if there are extra embryos that are created there that are of high enough quality, they can be frozen and stored for future use. So that's how typical IVF cycle would work.
Speaker 2:Okay. And then today we're going to be talking about a relatively new, although it's not a, there's been research that dates back a while, but relatively, uh, treatment option called intra vaginal culture or IVC. So how does that compare and where does it fit into the, uh, the traditional treatments that you've just mentioned?
Speaker 3:So, intro vaginal culture is a fairly new form of treatment, um, that is becoming more mainstream. That fits in nicely in between, uh, injectables, injectable kinetic Tropez with IUI and an IVF cycle. The key difference between IVC, um, Inva cell treatment versus traditional IVF is that within VSL, the patient herself is the incubator for the eggs and embryos rather than an IVF laboratory.
Speaker 2:And let me pause here and say that we're using two terms, intra vaginal culture as well as Invo Sell Info sell, uh, is we, we sometimes hear it referred to as that because they're the manufacturer of the device that is inserted into the woman's vagina. Uh, and so that's why you may, uh, I, I certainly know from our audience that they, they seem to use info sell as frequently as they do intra-vaginal culture. So
Speaker 3:yes, yes, I'm determined to settle is because becomes synonymous with intra-vaginal culture.
Speaker 2:Yeah, it has actually, uh, they may not want that to be the case, but I did. I think it has actually in this case. Um, okay, so you're kind of of putting it in between, uh, an IUI. Uh, but before you move to IVF. Okay. So what is the, what first of all, what is the IVC intra-vaginal culture process?
Speaker 3:Well, it starts with a Varian stimulation, like I would,
Speaker 2:okay. Same as so, so injectable gonadotrope Vinson.
Speaker 3:Yes. And um, now here is where you can see some variability from one clinic to another. Um, because the end of the cell is really about the interventional culture, but some clinics are using it in different ways. Um, I think the majority of clinics are using it in a way similar to how we are and we're, we're using Invisio in a way that gives patients another cost-conscious treatment choice. The imbecile device, like I said, has become synonymous with intra-vaginal culture because it's the first FDA cleared system and there's nothing else on the available yet that's like this. So to make it cost-conscious, what we're doing is having patients go through varying stimulation, but with the intent on getting a smaller number of eggs than we would normally get for a regular IVF cycle. That reduces the cost in two ways. One is that the injectable ins are very expensive and by targeting a smaller number of eggs, the patients takes a lower dose of the medication. The second reason is that, um, the response to the ovaries with a lower dose of medication is more predictable and we don't have to do as much ultrasound monitoring for a patient while she's doing ovarian stimulation. Um, the egg retrieval procedure is the same technique, uh, as a regular IVF egg retrieval procedure, the patient undergoes conscious sedation anesthesia and we use a vaginal ultrasound to guide a needle that goes through the vaginal tissue into the ovaries to extract the eggs. It's a short 10 to 15 minute procedure either way, but then, uh, the key difference is that instead of bringing the eggs into the IVF laboratory for the next five days, the only stay in the IVF laboratory for about 15 minutes. Once we've extracted the eggs, we combine them with the sperm and we incubate them together for about 15 minutes. And then we, by that point, sperm has already, um, started getting through all of the cells that surround the egg and are approaching the eggs outer shell. So we take the eggs and place them in the[inaudible] device and then we insert the Innisfail device into the patient's vagina along with, um, a retention device at the end of the cell comes with, which is basically a diaphragm. So that helps, um, keep the initial device at the top of the vagina. And at that point the patient's able to get dressed and go home. How many embryos can be grown cultured in the MSL device? Well, at this point there doesn't appear to be a limit. Um, now we're targeting somewhere between five to 10 eggs per patient at the time of the egg retrieval procedure. And on average we're getting about nine and a half eggs and we can put all of those into the MSL device along with the sperm. And it doesn't seem to, um, um, to, to, to have any negative effect at this point to have 10 eggs versus only five. Okay. So potentially what's the process? Are you cold? Are you cultivating for three days, five days to the blastocyst state or what? We're culturing until the blastocyst stage that stay five, uh, five days of development. Um, now the device is FDA cleared up to three days of embryo culture. Um, and so I should say that it is off label to use it for an additional two days. But, um, there is already a, a body of evidence in the literature where many centers are culturing it for five days and getting very good results. And we found that that's uh, our experience as well. So the patient comes back five days later and we'll remove the Invisalign device and the embryologist will then, um, remove the material that's there. And, um, we are able to find out how many high quality embryos we have at that point and then immediately do the embryo transfer.
Speaker 2:And Are you, if there are, uh, assuming that you generally will transfer just one, can you then also freeze any, uh, excess high quality embryos for a later attempt?
Speaker 3:Absolutely. And that's part of why this form of treatment is such a great value to patients. Um, because not only are the pregnancy rates, um, quite high, but the potential to have extra embryos to freeze for the future children or future attempts at pregnancy add a lot of value to this process. And um, and many people realize that proceeding down this path of treatment will give people the opportunity to have other children in the future without having to do more involved treatment such as regular IVF or go through another egg retrieval procedure.
Speaker 2:And, and you're comparing now the IVC two IUI and with IUI you don't have that option with IVC, you might have that option. Correct. And then of course with IVF you would also have that option. Right. Okay. So you've talked about some advantages to the, uh, that we're going to, well, let's go ahead and talk about costs. You mentioned that, that uh, IVC is a cost conscious, uh, alternative to IVF. So how do the costs compare and obviously there's going to be some range obviously with medication and other thing, but like turnkey costs. How much would a typical IVC cycle range in cost versus a IUI versus an IVF?
Speaker 3:With the way we're using, um, intro vaginal culture with the Inva cell, uh, we are pricing it so that it is just over 50% of its typical cost for a regular IVF cycle. Um, but our pregnancy rates are very similar to irregular IVF cycle.
Speaker 2:Okay. And that was good. Maybe you're anticipating my next question. Okay. And so it would be more, well that's an interesting thing. I was going to go back to comparing it to IUI, but that, you know, IUI if you're using injectable gonadotropins is not inexpensive. I mean we think of IUI as being inexpensive, but once you start putting them on the, the injectables, which then require significantly more monitoring because we don't want to end up with, you know, octuplets or whatever quadruplets are, are, are large in a large order multiples. So how would typical cycle with info cell compare to an IUI? Let's say with injectables?
Speaker 3:I think that if a patient has a good ovarian reserve, she shouldn't need high doses of injectable Ergonomic tropin. So I'm kind of doing some math in my head here. You know what the cost of one in the cell cycle would be approximately the same cost of three cycles of using injectable gonadotropins with IUI.
Speaker 2:Okay. That gives people a real, that's a perfect grant. Okay. So basically it's situated price range and, and you know, we talked money because the reality is for many people, if, if infor, if insurance is not covering it and for most people in the u s it is not covered by insurance, um, and so they're paying out of pocket. So cost is something that is, um, is, is critical to them and is certainly a motivating factor to consider. IVC.
Speaker 3:Absolutely. Um, it is usually a part of my conversation with every new patient consultation I practice in a state that is not a mandated state for fertility coverage. So knowing the cost is a huge part of the equation in helping patients decide what path is best for them to go down when you're looking at their treatment options. That's what I think is so great about it in the sal is that it is a cost conscious option and it gives patients access to another form of treatment was very good success rates, uh, at a cost that many people can, can afford who otherwise wouldn't be able to do regular IVF.
Speaker 2:Right. And that's the, and from our standpoint, one of the reasons we're interested in covering it is that we want more, we want more access to care and costs is a, is a function of that. So yeah, hence why this is an important topic.
Speaker 4:Let me pause for a moment to let you know that this show is underwritten by our corporate sponsor fairing pharmaceutical for women who have been undergoing fertility treatment and are still struggling to conceive ferring wants you to know about the verticam. Yeah. It was designed specifically to help limit address the mini challenging emotional life situations that inevitably arise when struggling to conceive. There are, they include a, the app includes a daily scenarios and interactions and gives you some tried and true coping techniques developed by Dr Ali Domar and Dr Liz Grill, which are both protective psychologists. Even get more information about the first comment@virtacalmapp.com and that's f e r t I calm c a l m
Speaker 2:app.com. All right, so the, I guess the$64 million question is, is talking about pregnancy rights because obviously that's what, uh, that's what we're all seeking. So how do the, uh, pregnancy, how does per cycle pregnancy rates compare from a, a set from IBC to I've, well, let's say IVC, I wanted to compare it to both IUI without injectables, IUI with injectables and IVF. You could take that in any order you want.
Speaker 3:Um, I feel like I'm in a new patient consultation now.
Speaker 2:Yeah. Well, Yup, that's what you get paid the big bucks for it.
Speaker 3:We can certainly run through those and I'll, um, I'll give, you know, numbers that I would normally give a new patient that I'm meeting a perfect. Um, and if we look at pregnancy rates using oral medication, um, combined with IUI, I mean historically the pregnancy rates have been a little over 10% per cycle. And when we constantly follow our statistics, that ends up being the case. We can see pregnancy rates of 12 to 15% per cycle here in our patients.
Speaker 5:Okay.
Speaker 3:If people move up to the next option and look at injectable gonadotropins with Rui, you can see an increase in pregnancy rates, but it's not a doubling. We go to about a 22 per a 20 to 22% chance of pregnancy each month with gonadotropins and IUI with invis cell. If we look at all cycles that have been done here so far and have started ovarian stimulation, we're seeing pregnancy rates of 65%. And with Ivs, if we look at a similar population of patients, we're seeing pregnancy rates of about 75%. If we, if we look at pregnancy rates and anything that involves an embryo transfer, uh, there's two different ways of reporting those pregnancy rates. One is to look at all patients who begin the process or what we call a cycle start and then we could also have a different denominator called the the actual embryo transfer procedure. Um, and the reason for having those differences is that some patients who start the process don't actually end up putting an embryo back into the uterus. And what's very interesting in our experience with the MSL is that if we look at the per embryo transfer pregnancy rate or just over 90%
Speaker 2:yeah, let me see if I can understand it and say that in another way you can start a cycle, but it may end up that you have no embryos to transfer. So that rate is going to be different for the, you would expect the number of people who start a cycle to be greater our, the, the pregnancy rate to be less because you're going to have some drop out because there will be people who are not getting embryos in order to transfer. Am I, am I saying that correctly?
Speaker 3:That is exactly right. And that how I was just about to explain that and that I can happen in, in regular IVF cycles where, you know, we, we get to the point where there's either no fertilization of eggs or the embryo quality is too poor, but it can also happen in, in the cell cycles. Um, and so in the cell has great pregnancy rates when we have a good embryo, but there are a proportion of patients who will have um, poor fertilization in the end, the cell device or they just didn't start with as many eggs as we wanted them to and they didn't end up with a good embryo.
Speaker 2:So is the, um, I don't know the right term for this, um, is the culture, um, that's not probably the right culture. Failure would not be the right term, but does in, in vi, does IVC have a higher percentage of embryos that would not develop to the transfer stage, not become transferable?[inaudible]
Speaker 3:um, the way I would explain how I interpret this phenomenon is that I think that the infantry intra-vaginal culture technique and device worked very well because the quality of the embryos we're seeing, um, for many of our patients is very high. Um, we've seen some very beautiful embryos coming out of the into cell device, but some patients, um, we are learning the hard way, have fertilization failure as an infertility costs. Uh, when we're doing traditional IVF, we are usually doing the ECC process, which is intracytoplasmic sperm injection. That's when we assist with fertilization by injecting sperm into the eggs. But when we're doing infant cell, we are not able to do z. And so we can assist with fertilization and we're relying on that to happen more naturally. And so we, we've had a number of cases where patients have come back and we found that none of the exit fertilized, um, I don't think it's a culture problem. I think it's a fertilization failure
Speaker 2:and those patients would not see that in a, how you practice a standard IVF cycle because you're going to be using ECC, which is when you grab one sperm and literally poke it into an egg. So you're manually fertilizing the egg. So if that, the assumption would be that the problem that they were having is that they needed ECC, which is not a part of the IVC process.
Speaker 3:Correct. Not For us. I know that there are some clinics that are doing[inaudible] with the imbecile though.
Speaker 2:Well, I'm going to come back to that how you would, you mentioned at the beginning that there are some different ways and we'll come back to that at the end. Okay. So, um, so we, uh, there are going to be the patients who, whose fertility issues are most likely, uh, centered around the actual fertilization, the sperm getting into the egg. Those patients, uh, you would find out through IVC that that's, that's where their problem lies and they would need to move on to IVF. But assuming that that isn't the cause of their infertility, then the, the, you're seeing a relatively high development of embryos through the, uh, inverse cell device?
Speaker 3:Correct. Okay. Excellent. In our population of patients who have done this so far, um, we are averaging a little over two high quality embryos heard cycle. So about 50% of our patients who go through have an extra embryo to freeze or maybe even more than one.
Speaker 2:And in a typical IVF cycle you would expect more?
Speaker 3:Yes. On average. That's right. If we look at the similar population of patients that are doing invis sell that, that would be the case. My expectations would be higher just because we're aiming for more eggs in a regular IVF cycle, we're likely to have a higher number of embryos developed from those.
Speaker 2:You're using Morgan Anna trope, but you're doing more stimulation of the ovaries generally. So from what you were saying,
Speaker 3:that's correct.
Speaker 2:Okay. So, um, we've talked about cost as a advantage or something to consider about, uh, using IVC. Are there some other advantages from you for using a woman's vagina as an incubator versus using a laboratory incubator?
Speaker 3:Yes. Um, there are, I would say a fairly high percentage of patients who are, um, intimidated or deterred from doing it more advanced treatment because of how less personal it is, um, about how it's too technological. And some people may feel that that's a lot less natural and um, but if you look at the invisible device and how the female patient can be the incubator to these embryos, um, for many patients it feels a more natural that they know that this embryo development is supposed to be happening within her body naturally. And though it's not happening within the fallopian tubes, in a device in the vagina, instead it's still much closer to being natural than an IVF lab.
Speaker 2:The psychological issues, yeah. Or, uh, there have been some surveys of women who have, and there's, uh, a fairly high patient satisfaction. I think. Um, one of the things that infertility does for, particularly for women and probably for men as well, is that it leaves them with the feeling of being out of control. And a feeling that their body is not functioning the way it's supposed to. Their body has failed them in some way. And, and the, uh, the use of a device such as the inverse cell device gives them back a sense of control and actually allows them to feel as if their body perhaps is, is, is stepping up, you know, it's doing part of what it's supposed to do. So I do think, are you also seeing from a psychological standpoint that patients are, are feeling better about the process because of the fact that they're involved?
Speaker 3:Yes. Yes, definitely. So, and then another patient population that has found this to be a good form of treatment for them are lesbian patients. Yeah. Um, there was a big news story that came out in the fall from a clinic in Texas and, uh, there was a lesbian couple who went through invis cell, um, where one partner care the entire cell device for five days, but the other partner had actually gone through the embryo transfer procedure. So they got to, to both share as much as possible in the process of having a child together. And, um, of course, you know, no other treatment option will allow a couple like that to be able to share in the process in the same way.
Speaker 2:Yeah. Yeah, that's an interesting as a case where, uh, again, it's more shared parenting and that sensor as that article said, we both carried our baby. Um, so what about the, um, the, the similarities that you mentioned earlier? I mean, generally speaking and in, in natural conception without fertility treatment, uh, the egg and the sperm meet and, and the early embryonic development takes place in the fallopian tubes. How does the, the vaginal environment, because let me go back and say that these invo cell devices are gas permeable, uh, as I understand it, which would mean that some of the environment, uh, that, uh, the vaginal environment is influencing the, the media and the embryo development. How does that vaginal, uh, environment compare to the Fallopian tube environment?
Speaker 3:Well, the actual environment is quite different. But what makes the conditions similar really is the end of the cell device and the eggs and sperm that are put into the, in the cell device are, um, within culture media. And that media has all of the nutritional needs of early developing embryos. And as you mentioned, the[inaudible] device is gas permeable. So, uh, we know that the Fallopian tube environment as a low oxygen concentration environment, um, the vagina is to, um, but with the exchange of the gases through the MSL device, this has allowed the Ph of the culture media inside the MSL device to remain neutral around 7.2 to 7.4. Um, and the temperature of course is optimal. It's, it should be the same temperatures within the, the pelvis and the Fallopian tubes. So, um, uh, yeah, the, the, the vaginal environment is different. Um, the Ph is more acidic, but it's really because it's a low, um, oxygen concentration environment. Um, at the right temperature is why the imbecile device can still work well.
Speaker 2:And then there's also of course, the fluctuation in temperatures because we know that, that our body temperatures fluctuate, not, not insignificantly throughout the day. Now I realize that that can be mimicked in a lab, um, environment and it is very successfully, but does, um, is there any, uh, is there any plus to the fluctuations that take place within naturally within a woman versus a, an incubator which is set to also fluctuate or most of them are, as I understand it?
Speaker 3:Ah, that's a great question. I think that, um, to really answer that someone would need to design a study and, um, compare eggs and embryos from a patient and put them into two different conditions and see, you know, how it works out in the end in terms of how many good quality embryos are present and uh, um, and, and we need a fairly large number of patients. So I think it'll be a little while till I can give you a good answer on that one.
Speaker 2:Yeah, I look forward to it. I look forward to when, and I've not heard of anybody who's getting ready to publish on that, but if you hear of it, if you let us know, we will sure follow it and report it out to our um, extensive audience. Uh, I would like to see that result as well. I mean there's some common sense there but, but also, you know, hard to know how it would actually play out. Yeah.
Speaker 4:Let me pause a moment to thank two of our partners, our partners, our clinics in organizations that believe in our mission of providing unbiased, medically accurate information to patients and to their allied professionals. And uh, they go beyond just saying that they believe in patient education and in bridging the gap between research and the patients, they actually put
Speaker 2:their money behind us in order to support this show as well as all the resources we provide. Let me tell you about two of our wonderful partners who presurgical fertility and genomic solutions are global leaders in IVF and reproductive genetics. They offer PGT, a, P, g, t, m, P, g, t, s, r and ERP PSM, endometrial receptivity testing for individuals. And couples who are planning a family and pursuing IVF. And, and for me this is really important. Uh, Cooper genomics is also proud to provide comprehensive genetic counseling to their patients. I think that is so important and we're so happy to have, uh, Cooper genomics as one of our partners. We also have a reproductive medicine associates of New York. They are a full service fertility centers specializing in, in vitro fertilization, egg donation, egg and embryo freezing, LGBTQ family building, reproductive surgeries, and male reproductive medicine. Highly individualized patient care is offered through 13 reproductive endocrinologist and fertility specialists plus they have a urologist and a full support team for their patients. All right. Now are there specific patients who are better suited to use IVC or who should not use IVC? Uh, and I'm thinking about things like their AMH level are their, uh, uh, FSH level are, um, uh, repeated failures or things such as that.
Speaker 3:That's a great question. I'm glad you brought that up because that's definitely something I wanted to clarify in our conversation. The way we're using imbecile, um, which is what most people call a minimal stimulation, uh, protocol to, um, to stimulate the ovaries. We want to make sure that the patient has a good prognosis for being successful with this. And what we're doing is limiting and VSL to women who are under the age of 38 because a quality declines with increasing age, uh, and we want them to have an AMH of around 1.5 or more because the AMH level is very predictive of how well one's a reasonable respond to medication and how many eggs we can get at the time of the egg retrieval. Um, we do have a BMI cutoff two, it's at 37, but that's not specific to in the cell. That's actually for all of our IVF patients because we feel like there's enough evidence in the literature that ties, um, elevated BMI is to lower chances of success. And so we encourage people to, um, to get their BMI down before going through the treatment. And because the fertilization is happening in a more natural way, we want to make sure that they have good sperm quality[inaudible]
Speaker 2:so they have to have a normal sperm analysis, I would assume because you're not going to be able to do any form of exterior or uh, enhanced fertilization. That's correct. Gotcha. Okay. And um, if someone has failed at IVF, uh, but meets these other criteria, are they eligible and by saying failed by IVF, what I mean is having a IVF cycle that did not result in a pregnancy?
Speaker 3:Well, um, I think some patients could, I don't want to have a blanket statement to answer that question. If, if I have a patient who goes through traditional IBF and fails, I always have a follow up to try to help understand why and what, what we've learned from that cycle and to help guide the patient about what their next next steps ought to be. For some patients in facil would not be a good choice. Um, if a patient had a poor response to medication or let's say a patient had a good number of eggs, that retrieval and fertilization went well, but embryo quality was very poor. Uh, I'm, I'm not optimistic that imbecile would produce any better results. So I wouldn't recommend going down that path. But if somebody did make good quality embryos and they had implantation failure or they had pregnancy but in early miscarriage and they didn't want a larger number of embryos, I think MSL would be an option, a viable option for that patient.
Speaker 2:And I'm glad you mentioned that. Um, there are, there is definitely a, and I think it is a subgroup, but we certainly hear from them and I think we hear from them because we're a[inaudible]. Uh, we're a play fairly neutral place and we're a safe place for them to vent this. But there are definitely patients who worry about the creation of excess embryos and they worry about it because they are not sure what their options are. They may well be sure of what their options are, but they don't have any options that they, they don't want to create more embryos in. They're willing to try to transfer and have as children. And uh, how would a I IBC, how would that, would this be a good option assuming they meet the other criteria for families? Uh, who are our patients who do not want to have excess embryos leftover or want to limit the number?
Speaker 3:No, that's, that's a great point. Um, that's right, that when used with a minimal stimulation protocol, the likely hood of having a large number of surplus embryos is going to be lower compared to traditional IVF. And you're right, I've had said, I've sat down and had some very emotional conversations with patients who ended up having, you know, six to eight frozen embryos and now they have a problem that they never imagined. Exactly. And it's a very difficult decision, um, to decide how, what to do with these extra things.
Speaker 2:It is enough for everyone, but for when it is a difficult decision, it's heart rendering. And we've certainly walked with a number of people down that path. So how does, uh, uh, the info sell, uh, procedure compare with either IUI with injectables are with IVF for the risk of multiple pregnancies? Because let's be clear the, uh, what our goal is is to have one healthy singleton. That's right. So how does it compare on that risk?
Speaker 3:Because we're using this in patients who are under the age of 38, our standard is to only transfer one embryo at a time. Um, and that's the best way to minimize the chance of a multiple pregnancy. So, um, in, uh, in lately our multiple pregnancy rates from anything IVF or in Pacelle related has been less than 5%.
Speaker 2:And so that's your same standard for IVF too. So you would be doing the very same. What about IUI then? How would it compare?
Speaker 3:Well, when we're using IUI with Clomid or Letrozole, the twinning rate is very low. It's probably around 5%. Um, and it's the, the chance of twins is really predicted by the number of follicles or eggs that develop in response to the medication. So when we use[inaudible] injectable gonadotropins and we're intentionally stimulating multiple eggs, that's when we can see twinning rates of 15 up to 20%. And I have to admit, we still see the occasional higher order, multiple pregnancy, you know, even triplets a, I don't remember the last time we saw quadruplets, but that's the, uh, now the more common way to have a multiple pregnancy is through injectable gonadotropins with IUI. And there is a trend now where, um, many clinics are really trying to avoid injectable gonadotropins and IUI for that very reason. Having, you know, encouraging patients to go from, uh, oral medications directly to IVF.
Speaker 2:[inaudible]. Yeah, I think that's something that we've certainly talked about on this show. Um, but, uh, it's a myth to think that the, especially the higher order multiples are coming from IVF or IVC. Um, they generally are coming from, um, uh, yeah, IUI is with, uh, uh, injectables, uh, because even with the best of monitoring, it is still possible to result in, uh, in higher order. Okay. You had mentioned that there are other clinics are, uh, using, uh, the invo cell you're using. Not every clinic is, is using it the same way. What are some of the variations that are, our listeners may, may see when they start talking about this
Speaker 3:or that some clinics are doing a full dose ovarian stimulation protocols, uh, rather than minimal stimulation protocols, um, aiming to get a larger number of eggs. Um, that's one difference
Speaker 2:that would affect the cost savings. However, would it not
Speaker 3:correct a Morgan at a Tropez would be used and generally you will see more monitoring appointments to some more ultrasounds and blood tests along the way. Okay. Another difference is that some clinics are doing XC, um, so rather than letting the sperm fertilize the eggs, naturally the eggs are going through the[inaudible] process. Um, but the timing of[inaudible] sometimes is different. And, uh, because of the extra work being done in the lab, the patient will not have the in facility device inserted immediately after the egg retrieval. The patient will come back later in the day to the IVF lab after the XD process has been done and then have the imbecile device inserted. Um, but then she'll culture for five days and come back. Those are two of the, the big differences that I've heard of.
Speaker 2:And I have you read, uh, um, do you know how they're, uh, how the growth embryo growth is for those that are using ECC versus, oh, cause we talked about, uh, a, uh, a higher percentage of women not getting enough embryos to transfer, um, with IVC. Do you have, is, uh, what are you hearing as far as the, if they're using ECC, is that preventing that problem or is it just too early to tell?
Speaker 3:It's a, I think it's a little early to tell, but from, from what I've heard through other sources is that when exceeds being done, it can certainly minimize the chances of fertilization failure. Um, and you're more likely to have embryos available to transfer that way. Um, so, but, but I haven't heard actual numbers or statistics.
Speaker 2:Yeah. I haven't seen them either. And then also though on the, the counter argument would seem to me would be that your cost would, because obviously that's a more expensive procedure and, uh, so your costs are gonna start increasing. And at what point, uh, if your costs are close to IVF, do you, do you use IVC versus going straight to IVF?
Speaker 3:Yeah, I, um, I had the same question and I think that, um, some clinics, uh, have, um, found a position for Invis l within their, uh, different treatment options. That's a, that's different than ours. Um, I think that, you know, the intra-vaginal culture process works, um, in, in, by avoiding the IVF lab, that is still a significant cost reduction. Um, but I think that if, you know, people are using higher amounts of gonadotrope and in adding an XC that, um, there's probably a little bit of cost creep. But, um, you know, in, in for some clinics, the, there's still maybe considerable savings for patients and it still may be a good option, but we're, we're trying to keep the total cost to just, you know, very close to half of a regular IVF cycle. We think that that's a nice place for our pipe patient population that really improves accessibility.
Speaker 2:And now let's talk about what, uh, the published research is showing. There isn't a huge amount of published research that I've seen, but that would make sense because it's a relatively new procedure. Um, what, what are you seeing in the research?
Speaker 3:Um, one of the more recent papers was from, um, a practice in Texas and, uh, at care, uh, and they published a paper using blastocyst culture and um, comparing, um, some patients who are doing traditional IVF to doing intra-vaginal culture and they show that the chance of having a high quality embryos is very similar between the two. Interesting gay five culture
Speaker 2:are, are there still clinics that are only using, uh, are, are only cultivating for day three, which is, is actually what it is approved for. Our most people are most clinics now still going to day five.
Speaker 3:Most clinics are going today, five. Um, when they, when the manufacturer sought FDA clearance, um, you know, this was almost 10 years ago and, um, you know, there were still a lot of centers that weren't doing day five culture yet. So, um, they only included studies that did day three culture, um, within interventional culture. But now I, I, I think only a small percentage of clinics who offer this or are sticking to day three culture, um, under when used with the proper media. Um, we're still seeing beautiful embryos coming out of MSL going out to day five.
Speaker 2:Yeah. The Sh the, the practice, the, the, that was considered best practice now has shifted from 10 years ago, uh, to where exactly. So that, that would make sense. Uh, and is the culture that is being used, uh, in the invis cell device, the same culture that would be being used if it was being cultured in a laboratory?
Speaker 3:Uh, are you referring to the media itself? Yes, we're using media that was originally designed to be used within the IVF lab. Um, and this particular media is specifically used for time lapse, um, uh, incubators, um, which is, uh, immediate that was designed to be kept in place for the full, um, culture period out to the blastocyst stage rather than being changed periodically. So it seemed to be appropriate for a device like this that we were planning on having the patient keeping the vagina for five days.
Speaker 2:Yeah. You're going to take it out and change the culture. Right. Okay. All right. So it is, it is a, one of the standard media that is uh, was already developed for laboratory use. Correct. You know, it occurs to me that, you know, when we talk about access to care, um, certainly our audience is, is mostly u s so that we have a, an international, but obviously they'd have to be speaking English, but there is also an accent. So, so when we think of access to care, our audience is generally thinking of access to care here in the United States or England or our, our Australia or our Canada or any English speaking country. But we have a whole other access to care issue. And that is for, for women throughout the world, um, who don't have access to the high quality infertility treatment that's available here in the u s available. If you've got the, the, you know, if you can afford it, but still available here in the u s is there a possibility of using, um, IVC or info cell because it seems like you wouldn't, you would be, it would be easier to set up a clinic because you wouldn't have to have the lab and everything? Or am I making this too simplistic?
Speaker 3:No, I, um, I think that's a great point. In fact, I know that's already been done. There's a, a physician in group in Texas who opened a clinic specifically for, in the cell for patients of, uh, you know, lower second socioeconomic status, uh, who didn't have insurance coverage. And you're right, you wouldn't have all of the startup costs of buying all of that expensive laboratory equipment. Right. And having a need for a larger staff to work in that IVF lab. I've also heard of other clinics opening up in this country to um, focus, just doing it, focused on just doing invis l um, and so yes, I mean it definitely helps improve access to care. And, and another thing to consider is that if you look at the geographic location of these IVF labs, they're all clustered in the large cities in the large metropolitan.
Speaker 2:Such a good point. Yes.
Speaker 3:There's so many women throughout the country, I mean hundreds of thousands who don't have access to care because they just can't travel the distance. Yep. And this is one of the areas that has helped, um, you know, patients in our state because we have many patients now doing of the cell who live one to two hours away and don't have to go through as many appointments as they would for traditional IVF because of the less monitoring. Uh, and they also don't have to think about having, going through IUI cycles month after month though. There's fewer appointments per cycle. The idea of going through those several appointments each month for three, four months at time, uh, is daunting. And these patients, they have to take an entire day off.
Speaker 2:I was going to say, not only daunting, but, but time consuming and, and interferes with their work in a significant way. Uh, yeah, I mean exactly.
Speaker 3:So being able to provide a form of treatment with a much higher success rate with a less of a time commitment and compared to traditional IVF is it's just, it's been a great option for many patients in North Carolina.
Speaker 2:[inaudible] yeah. And throughout, uh, we, uh, again, uh, people from the large metropolitan areas often don't appreciate that outside of large metropolitan areas[inaudible] people have to travel and, uh, and you're exactly right. They have to take off from work, uh, and the more appointments. So yeah, that's an interesting point. And I also just can't help but think in other countries as well that, uh, do you know of anybody who is thinking about trying to expand to provide coverage throughout the world, um, you know, in a more cost effective way?
Speaker 3:Um, no, I'm, I'm, I'm sure that that's happening. I've heard that that's happening, but I can't give you any specifics.
Speaker 2:Yeah. Okay. I'm just curious because I find it again, it's up. The, the whole idea of access to care is something that we talk about a lot and uh, and this is an interesting option for increasing uh, care for people or just everywhere, including in the u s
Speaker 3:and another thing to consider for the patients that we're using in the cell, where are the patients who need donor insemination? Um, patients who are using donor sperm because their male partner may not have any sperm or if we have some single women or lesbian couples, this is a great option because now the patient only needs to purchase one sample of donor sperm. On the other hand, if the patient were going through insemination cycles, you would likely need to purchase three or more samples of sperm. And because, uh, the way of doing MSL gives us a strong possibility of having extra embryos to freeze. There's the possibility then that the patient will have genetic siblings to their first child, um, as a frozen embryo and then they won't have to worry about purchasing extra samples of sperm for future children or whether the donor that they're using will have any samples available.
Speaker 2:Yeah. Whether that donor, and sometimes they have to purchase an advance because they want to make, if they want to make certain they have full genetic siblings. So from the standpoint of a patient considering this, assuming that the, uh, the woman does not have fertility issues, that it still might work out from a cost effective standpoint to go through the stimulation and the egg retrieval and Andy then and do donor sperm because they wouldn't have to buy multiple vials and because the, they would hope that again, because especially because she likely doesn't have fertility issues, they would hope to end up with at least one extra, uh, frozen embryos so that it could even be, we would, it worked out, but to be more cost effective to do it this way,
Speaker 3:it could work out to be more cost effective in the long run. That's right. If their goal is to have more than one child. Interesting. And this is something that patients should strongly consider. Yeah. Insemination, pregnancy rates. Just you know, the spontaneous conception rates are a little over 20% per month for women in their twenties and early thirties. So we can't expect a donor insemination rates to really be any better than that if we're doing natural cycles or using Clomid. So on average it's going to take more than three cycles to have the same chance of pregnancy, um, or than three cycles with IUI using donor sperm to have the same chance of pregnancy as one attempted embassy.
Speaker 2:Wow. Okay. That's fascinating. Well, thank you so much Dr. John Park for talking to us today about intro vaginal culture.
Speaker 4:Let me remind everybody that the views expressed in this show are those of the guests do not necessarily reflect the position of creating a family, our partners or our underwriters. Also keep in mind that the information given in this interview is general advice to understand how it applies to your specific situation.
Speaker 2:Work with your infertility professional. Thank you for joining us today and I will see you next week.