In this episode of The Egg Whisperer Show, I had the pleasure of talking with Dr. Andrea Vidali, a leading reproductive immunologist whose groundbreaking work has significantly advanced our understanding of IVF, miscarriage, and the complex role of immunology in fertility.
Dr. Vidali’s journey in reproductive medicine is impressive—his extensive education, research, and clinical work have made him a true pioneer in this field. We discussed his unique approach to fertility care and why he believes so strongly in the power of reproductive immunology. For many patients, immunological factors can play a crucial role in fertility challenges, and Dr. Vidali’s work has helped illuminate just how critical it is to understand these complexities.
During our conversation, we tackled some common myths about reproductive immunology, including whether immune system compatibility truly matters in fertility and pregnancy. Dr. Vidali explained how personalized testing can uncover specific immunological issues that may be affecting an individual’s fertility. He also shared insights about his healthcare information company, Preg Mu, which specializes in providing a comprehensive look at patients’ reproductive immunological health. This company advocates for a customized approach, empowering patients and practitioners alike to explore solutions rooted in detailed immunological testing.
In this episode, we cover:
- Dr. Andrea Vidali’s impressive background in reproductive immunology, endometriosis, and miscarriage.
- The principles of reproductive immunology, exploring immune tolerance in pregnancy and how the immune system interacts with embryos.
- Key immunological factors in fertility, discussing testing methods, the role of natural killer cells, and debunking common myths in reproductive immunology.
- Pregmune, his healthcare information company, which offers comprehensive immunological testing for fertility patients.
Resources:
Dr. Aimee’s fertility essentials
Transcript:
Dr. Vidali is a world-renowned reproductive endocrinologist, reproductive immunologist, and endometriosis specialist surgeon, miscarriage specialist, and he’s also the founder and CEO of Pregmune. He created Pregmune to help people understand their diagnosis and what may be playing into it. It’s a healthcare information company that leverages his research in the field of IVF, miscarriage, and immunology all in one place.
He also co-founded Braverman Reproductive Immunology with his friend and partner Dr. Jeffrey Braverman, as well as the Endometriosis Summit alongside Dr. Sallie Sarel.
He completed his medical degree at age 23 at the University of Padova in Italy and went on to complete a residency program in OB GYN at Georgetown in Washington DC and a fellowship in reproductive endocrinology at Columbia.
Dr. Vidali also carried out important research both in the surgical and IVF fields. In 1998, he published one of the earliest reports of egg freezing for fertility. In the same year, he also published one of the earliest papers on laparoscopic myomectomy for fertility patients.
I am so excited to share this conversation with you because it’s jam-packed with helpful information and resources. There’s no one better to discuss reproductive immunology with and I loved having Dr. Vidali on the show.
Dr. Aimee: I have world-renowned reproductive immunologist Dr. Andrea Vidali on today’s show. Welcome, Andrea. Thank you for joining us today.
Dr. Andrea Vidali: Good afternoon, Aimee. It’s a pleasure to finally meet you. Of course, I’ve heard so much about you, and I know about you, about your work and your research, and what you’re doing for patients. I’m very excited to have the opportunity to spend some time with you today.
Dr. Aimee: Thank you for making the time. I have to tell you that there’s probably only one doctor that I get a message about at least once a week saying, “You have to get Dr. Vidali on your show.” So, this is a long time coming. Thank you again.
Dr. Vidali: Thank you very much.
Dr. Aimee: I want to hear more about you and what brought you to the field of fertility. You made the choice pretty early in life. What interested you about this field from that young of an age?
Dr. Vidali: This moment in time when IVF was just starting and I was a young resident at Georgetown, that’s when it caught my attention. I felt the excitement. I felt the new thing coming up and how everybody wanted to be part of it. Of course, I wanted to be part of it too, because of the science and the novelty of the scientific discoveries. That’s what led me to the world of fertility. That’s what happened.
After that, I went to Columbia, and that was also a very exciting time. In fact, if we have a minute of time, I have a little anecdote for you. The first IVF cycle ever was actually done at Columbia University, but it never came to fruition. This is before, as everybody may or may not know, the first IVF was actually done in the UK, Dr. Steptoe and Dr. Edwards, the Nobel Laureates for the first IVF cycle. A lot of centers were trying to do IVF at the time. It wasn’t just the center in the UK.
What happened is that at Columbia at the time there was a great innovator, and the guy was like, “I’m going to do IVF.” What happened that day, the patient was at Cornell actually. They did a laparotomy, open surgery, believe it or not, and they took the eggs out. The doctor who did the retrieval, I don’t remember his name, sorry, but there’s actually an episode of This American Life talking about this. The doctor took his car – if you’re in New York, you know that Cornell is on the upper east side – and drove all the way up to Columbia University on 168th Street on the upper west side, and brought the eggs to the doctor. I wish I remembered the name of the embryologist. You could look it up. They fertilized the eggs and put them in the incubator. This is the age before there was a consent form, this was done like this, spontaneously. The patient, of course, was in full agreement.
The chair of the department at the time was Dr. Wande Wiele, who was a traditional Dutch guy, very traditional. He was like, “We cannot be the first people doing this. This is too risky for us, this test tube baby.” So, he went in at night, he opened the incubator, and he threw the embryos out the window of the 16th floor of Columbia University. It was actually a huge scandal. The patient actually sued Columbia University and there was a very public trial about this, and they got some sort of monetary compensation.
This is a little tiny bit of history of IVF that many of you today may not know about. Of course, I knew about it because I came a little bit after that. One of my mentors, Dr. Nabil Husami, also a former partner, a wonderful person who passed away a few years ago. He was there at the time, he was a fellow, so he’s the guy who told me about the story, and then I found out about it.
Sorry for the digression, but I thought it was an interesting factoid.
Dr. Aimee: No. I love it. That is an interesting factoid. I had no idea. Wow.
I want to talk more about your role and how you are a leader in the field of reproductive immunology. I hear from so many patients this question, “How do I know if I’m attacking my baby and my body is actually attacking my baby?” I know that might be triggering for some people to hear, but those are the words that my patients actually hear. I’m so happy to know that you’ve created Pregmune, and I would love for you to talk a little bit more about that, and we’ll get into it.
Before that, when we think about immunology and reproductive immunology, and the immunological factors that can play a role, what do you mean and what kinds of factors do fertility patients really need to consider?
Dr. Vidali: I’d like to first start with what you just mentioned, which is what your patients, our patients tell us. It’s really an intuition. The individual tells you, “Something is not right here.” Of course, we have to be careful because intuitions are not always right. Sometimes one can have an intuition and they are wrong. In this case, there is actually a lot of evidence that these intuitions are actually true.
One example that I can make, and I’m sure you hear this all the time, is sometimes someone is pregnant, and as soon as they get pregnant they start having rashes all over their body, they swell up, they feel inflamed, something is going on. It’s not very common, these are more extreme cases, but we do hear these stories. Of course, stories can be anecdotes and this is not how science is made, but the reality is this intuition that people have is actually correct. It’s not correct for everybody, like I said. You can’t base it on that.
What I’m trying to say is that what happens in pregnancy is that there is an interaction between two entities. One entity is the carrier, the mother, the parent. The other entity is the baby, the embryo. These two entities actually have something in common, but not everything, because 50% of the genetics comes from the father, the male partner. Why can this be a problem? We call the embryo a semi-allograft. An allograft is a transplant. You have to think of the baby as you would think of a transplanted kidney. Not exactly. I’m making a comparison which is not 100% correct, just to understand. We call that a semi-allograft. What that means is that half of the genetics of the embryo comes from the other parent.
Obviously, there are mechanisms in place to prevent rejection, because the natural reaction of the body would be to reject something that is foreign to the body. There are obviously immunological mechanisms in place, and we call these the development of tolerance, tolerance toward these antigens. How does tolerance get developed? The way in nature normally tolerance gets developed is by sexual interaction when the sperm enters the body, and the sperm contains the DNA of the other parent, and as the sperm enters the uterus, these sperm cells are recognized by certain specific cells called antigen presenting cells. These cells identify the specific antigens on the sperm and they present these antigens to other cells inside the body, immunological cells, immune cells, so that the immune system develops progressively a tolerance toward these foreign antigens.
There are studies that show that whenever these phenomena do not happen, whenever people, for example, do not have sex, one of the examples would be using donor sperm, in that case, we have seen that some of these tolerance mechanisms can be slightly altered. This mechanism of tolerance is very important, but it can be disrupted.
How can this be disrupted? It can be disrupted in different ways. It can be disrupted by a hyperactive immune system. There are such things as autoimmune conditions, and some people have autoimmune conditions. They are more common in women than in men. One of the reasons why this happens is because the immune system of a genetically female person is more plastic. Because of the pregnancy, there is more plasticity, and there’s more on and off switches. When you have more on and off switches, the switch can break, so the system breaks.
So, there are autoimmune conditions. The most common, of course, that we know about is thyroid disease. So common. Hashimoto Thyroiditis. There’s also Lupus, rheumatoid arthritis, and other autoimmune conditions. There could be a hyperactive immune system that then in turn disrupts the immune mechanism of tolerance.
There are also situations I call “in-between,” because it’s a continuum between health and disease. There isn’t a firm demarcation between health and disease. Often, you are healthy, then you are less healthy, and then you are less healthy, then you are ill, and then you are very ill. The immune system functions the same way. There are some people who find themselves in this in-between state.
The focus of the field of reproductive immunology is to look at all of this that I just mentioned, which is really the mechanisms that control the interaction between the carrier, the mother, and the embryo, ultimately the baby. Additionally, and I know that you spend a lot of time educating people about inflammation, when we talk about the immune system and we talk about immunology, we also talk about inflammation. When we talk about inflammation, we also talk about nutrition, so that whole other aspect plays an enormous role.
I like to mention this, because I know this is something that in your practice you focus on, the inflammatory component, which arises from different factors. One is your own natural immunity and disruption of that, but also what you put into your body, what you do to your body. I just want to give a general perspective of what we talk about when we talk about this.
Additionally, I would like to say that the field of reproductive immunology is not new. This is a field that has been around for at least 50 years. There is a Journal of Reproductive Immunology. This is established science. One of the problems is that there’s not as many doctors that focus on reproductive immunology. This is because medicine is very compartmentalized. You have the immunologist that deals with “immunological problems,” you go to immunology to see if you have whatever allergies, etcetera. Then you have the reproductive endocrinologist that deals with the reproductive issues.
Sometimes there is not a lot of crosstalk. This is always a problem, even in other fields of medicine. When you go outside of a specific scenario, the doctors are confused and they tell you, “I don’t know anything about that.” Typical thing, I don’t know how many times you get a call from the dentist that tells you, “I have to give anesthesia to drill a tooth,” and I’m like why are you calling me, this is what you do every day. But this is what it is, medicine is very compartmentalized.
I just wanted to give a whole general view of what we’re dealing with when we talk about reproductive immunology.
Dr. Aimee: I want to ask you a question. Do you think that a workup should be part of the standard at the outset? When you’re first starting your fertility journey, let’s say, and you’ve gone through your IVF cycle and you’ve banked your embryos, should patients also be doing a reproductive immunology workup, in your humble opinion, or is it something that you wait and do if you’ve done everything else and your first transfer doesn’t work or your second transfer doesn’t work? What is your opinion?
Dr. Vidali: I like to say something, which is that there are guidelines. In fact, ASRM just released guidelines for evaluation of the infertile patients last week. I was just reading them yesterday, and they’re no different than the guidelines that were released almost a decade ago. I’m like, “Really?” They are very basic, and I understand that.
One of the issues that we have is that there is an enormous time gap between guidelines that are determined by these organizations. It’s not just the ASRM. It could be the Royal College, it could be ESHRE, it could be the French Fertility Society, it could be the German Fertility Society, it could be the Chinese Fertility Society. One of the things about these guidelines, the first thing about it is that there is a gap in time. There’s about an eight year gap between when actual good research is done and when it enters the guidelines. A lifetime, basically. An enormous gap where good evidence that is available is not introduced. That’s one problem.
The second part is that there is tremendous discordance between different organizations. You would think that all of these different societies read the same journals, read the same literature, and you would think that they would be in agreement, but the answer is no, they are not, so there is a difference between these very standard guidelines that these experts put together. Let’s just agree that these guidelines are made by people, usually five or six, it used to be old white men. I think things are improving a little bit, but not that much. So, a bunch of old white men sit around a table, and they are experts, and they say, “We’re going to come to a consensus of what our interpretation of the evidence is.”
I just wanted to explain to people today what these guidelines actually mean. They’re like the lowest common denominator. We all agree on this. We are arguing about a lot of things, but we agree on that. So, these guidelines have a tendency to be very vanilla. It’s obvious the goal is to find something where everybody is in agreement. This is the reason why when you look at these guidelines, they are very limited in what they recommend.
Now, let’s get to your specific question. When should one worry and be concerned and consider doing immunological testing or any other testing that is outside of these guidelines? I’m not just talking about immunology. I’m talking about many other additional aspects.
My answer to that is it depends. The guideline should be something for everybody, but not everybody is the same. Not everybody has the same priorities.
One of the things that is extremely relevant and important, I believe, is the person’s history. What is their history? What is their family history? What is their personal health history? Not everybody has the same history. Some people have a family history of autoimmune conditions. Some people have a personal history of autoimmune conditions.
Let’s not forget the other part of it, which is very important, and I know this is very important, the age of the person. Obviously, if I am 30 years old, I may think that I have all the time in my life. But if I’m 39, 40, 41, 42, obviously there is more pressure on my part because I’m aware that I have less fertility time just because of the way nature works, so I may desire to be more aggressive.
The answer is that it depends. I feel that the more aggressive, more detailed investigation should be performed on individuals who already have either a positive history, or a positive family history, or based on their age. Ultimately, also based on their personal concerns. Sometimes people just don’t feel they want to go into one IVF cycle after the other without investigating a little deeper what the potential causes of the fertility problems or miscarriages are. I know perspectives differ in these contexts, but my perspective is that an effort should be made in trying to identify potential causes of infertility.
Fertility treatment or miscarriage treatment should not just be: a shake of the hand and IVF. That’s an option. I’m not saying that should necessarily be excluded. It’s certainly one path to take, but I don’t think it’s the only path.
Dr. Aimee: I want you to help me dispel some myths about reproductive immunology.
One of the things that I’ve heard, just because it’s how I’ve been trained, and sometimes you carry those things from training into your practice, and one of the things that I was always told is that the false positive rate with any of this reproductive immunology testing is really high, like 95% of the time you’ll find something that’s wrong, and whatever is wrong is not evidence-based. Based on that information, why even do the testing if you’re going to find out that something is wrong, if it really isn’t wrong?
The other myth is that checking peripheral NK levels really isn’t a reflection of what goes on in your uterus.
Can you speak to those things for us?
Dr. Vidali: Let’s start first with the role, what immunological testing goes to look for, and then we’ll look into the specifics of your questions.
When you talk about immunological testing, more specifically what I did in my own practice and what applies to the current test that we do at Pregmune, which is really an extension of that based on the science behind it, the testing focuses on different aspects.
The first part is this compatibility part that we just talked about, which deals with how the genetics of the couple play into the development of tolerance. This deals with certain receptors that are on the surface of immune cells, and these are genetically determined, and how these interactions play. This compatibility component, which is part of the major compatibility system, which is what is also used in transplant medicine. When doctors do this type of testing, they get a full transplant high definition HLA testing.
There’s actually quite solid evidence about these interactions. Specifically, when we’re looking at a specific fragment of the HLA, HLA-C, there is quite solid evidence about this. I think that a lot of the myth about this comes from the early ‘90s. The reason why there was a moment where immunology was sort of looked negatively upon is that there was a certain treatment called the Lit Procedure, a form of immunization which proved to be not very successful, and the FDA put a stop to it and the field kind of lost its momentum. Basically, after that, there has been 20 years of research.
The first component is the genetic component. The second component is looking at actual evidence of a hyperactive immune system. We’re talking about the presence of antiphospholipid antibodies, for example. There are specific recognized conditions. One of them is called antiphospholipid syndrome, which is associated with very elevated levels of antiphospholipid antibodies. This is all very solidly established science.
Additionally, of course, we also look at the nutritional component. When we were looking at the role of intralipids, and we can talk about that another time, we were not very convinced on the long term effects of intralipids. We looked at it and exactly what’s happening from that perspective, when you’re looking at omega-3s, omega-6s levels, and inflammatory parameters on a serological level, what happens there, and we looked at that and we added that part to our report.
When you do a lot of tests, it doesn’t matter what tests you do. It’s like when you go to the doctor and you do your health tests, if you’re the kind of person that goes to the doctor and does it yearly, and the doctor draws a million tests on you, then one test comes back abnormal. Of course, unless it’s a very important test, something very relevant, like PSA very elevated, that can be very important. But if it’s that one of the different parameters in your white blood cells is a little elevated, and the doctor tells you, “We did a hundred tests. That’s not a big deal.” There’s truth to that. If you do a hundred tests, you can’t really make a determination based on one test.
The way this has to be looked at has to be holistic. You have to look at all of the tests and what kind of clinical picture it depicts. This is the way to look at it. This is what we do at Pregmune. Of course, we also use artificial intelligence to obtain a meaningful prediction of success and to identify who is at high risk based on our original work that I had done in my clinical practice. That’s how we look at it. Certainly, you can’t base it on one single test itself. Of course, it’s a reasonable statement that you can just base it on one single test, but it’s not like that. You have to look at everything holistically.
One thing I’d like to add is that many studies on immunological treatment for either recurring pregnancy loss or implantation failure were and are done in Europe, mostly in Nordic countries. Mostly because they have, for some aspects, pretty good healthcare systems. I don’t think they’re amazing healthcare systems, but some aspects are good in the sense that they do provide medication for these treatments. So, there are some pretty good studies done in the Nordic countries utilizing immunological medications such as intravenous globulins, and other drugs like that in the context of randomized prospective studies. These medications are provided for free by the government, so they were able to do all of these studies.
Because these medications are very expensive and the companies that make them are not really interested in doing these big studies, in the US we don’t really have a lot of studies in this area. But we do a lot of testing. In the Netherlands and all of those places, they do the treatment without the testing. They treat based on condition. You have two or three miscarriages, and you get the treatment. You have implantation failure, you get the treatment. Here in the US, we do testing, but then sometimes patients have less access to the treatment.
So, there hasn’t been a lot of crosstalk. I was talking last week with Professor Franz Glass who is one of the greatest immunologists of transplant, and we were just observing that. One of the things we were trying to put together is communicating this type of information. So, yes, there are a lot of issues with communications and there’s a lot of that.
But I can tell you, I promise you that many reproductive endocrinologists today are ordering immunological tests. They just sometimes don’t know what to order. Sometimes they do it from pressure from patients, the patients are demanding. They are actually doing the testing, they are sending out the test, they just don’t know how to interpret some of it. They’re like, “This is high.”
You mentioned NK, natural killer cells, and I think everybody knows about natural killers, and I think it’s because of the name, this killer thing gets into people’s heads and they’re thinking killer has to be bad, so if I have a lot of these killer cells, it cannot be good. In reality, the picture is much more complex. Natural killer cells are cytotoxic cells that are part of our innate immune system. Our immune system is more evolved than some other animals. It’s a more evolved immune system than a primitive immune system. We have an adaptive immune system where we can adapt to what gets thrown at us and build more immunity, but it takes time, and that’s what vaccines work on.
Then we have the natural immune system. We have certain cells that they do not need to know what’s coming at them, they will naturally attack whatever offending bacteria or cancer cells comes and attacks them. These cells are part of the natural immunity. One of the theories of the Association has been that people who have higher level of some sub-types of these natural killer cells, this has been associated with increased recurrent pregnancy loss. As far as implantation failure, I’m not really sure that’s really that meaningful. Frankly, I’m not even sure that some of these connections are that meaningful.
Also, because one of the tests that gets ordered by doctors, they don’t really order the actual levels of how many natural killer cells. There are many subtypes. Depending on the receptors on the surface of these cells, there are many subtypes. The doctors do not normally order how many of these cells there are. They order a test called NKA, natural killer cell activity, which measures the ability of your own blood natural killer cells peripheral to kill a line of certain cancer cells, hematological cancer cells. So, it’s an in vitro test that tests the activity of these natural killer cells. These aren’t very good tests because a lot of these in vitro tests are so variable, there are so many different parameters that they can go off.
In my personal medical opinion, the NKA is a test to do, but you can’t base anything based on that. I think it’s very important that we take this into consideration. I mention that test because a lot of people ask about natural killer cells, but there’s a lot more to it. Like I said, the genetics are very important. That’s why I think it’s important to get a full clinical picture, a much broader, much deeper analysis than what one could do by just ordering that test.
Dr. Aimee: I think that makes perfect sense. You created Pregmune to help people understand their diagnosis and what may be playing into it. For doctors who are listening to this, because I know there are going to be reproductive endocrinologists that are going to be like, “I need to learn more about this,” when you see a patient and you provide a consult letter, I’m imagining the reproductive endocrinologist that’s taking care of that patient and doing their transfers will then look at it and take care of any of the action items that you want for them. Can you talk to me about that relationship between you and me, for example, when I refer a patient to you, and you’ve seen them, and you make recommendations? How do things work?
Dr. Vidali: Here’s how this works. When a doctor orders this report, basically this is what I used to do when I was just a clinical practitioner. The doctors would refer the patient, and I would order these tests, and it would be done in a much less sophisticated way. It was more like we would just look at this report, sit around the table and analyze. Now it’s much more automated. It’s done with a greater scientific energy approach as well, I would say.
When we make these recommendations, in the report there’s two levels of recommendations. One is a recommendation according to the standard organization, ESHRE, American Society of Reproductive Medicine, Royal College of Medicine, etcetera. As a physician, you get those recommendations, which are based on the “gold standard,” which is very stringent. You get those recommendations, and you may choose to follow them. Let’s remember that the therapeutic decision ultimately is up to the doctor. This is the way I see it, because it is. As a physician, you make your own recommendation. You may recommend a patient to do PGT or not depending on different factors that are also based on medical considerations that you make, the science, and the patient’s personal choices.
So, you have those recommendations, and then we have recommendations based on the literature, so on the current science. Obviously, those recommendations are going to be a little bit different, a little bit more aggressive than what the other recommendations may be. Then as a physician, you make your own considerations. In conjunction with the patient, you have a conversation, and you make your own recommendations on how to treat this.
When you’re looking at the science, and this is something very important, I like to discuss this. When we recommend the treatments, we base it on randomized prospective trials. One specific drug has been used the most in many randomized prospective trials, and that’s intravenous immune globulin, IVIG. That is expensive medication, but because we as a company at Pregmune have to stick to the standard of where the most randomized prospective trials were done, IVIG gets recommended more than anything else because it’s based on the science.
There’s obviously other treatments where there are less studies, but they are used more frequently because of the cost. That is the dilemma in medicine. Sometimes decisions, unfortunately, are made on cost. We all have to walk the Earth, you and I and all of our patients, we all have to pay our bills, and sometimes we also make medical decisions based on what we can afford. That’s just the reality of life.
For example, Prednisone, which you can think of like a huge hammer that you hit on the head of the immune system. Prednisone actually works as an immune drug. Before there were more modern immunological suppressant treatments, whenever people had transplants, they got enormous amounts of Prednisone. They still use it, but in lesser amounts today. Prednisone has a very deep and wide suppression of the immune system, but that’s certainly another alternative at lower dosages.
So, there’s different approaches a doctor can take. But the answer to your question is it’s really up to the doctor. We give the tools, we give a bird’s eye view. If you encounter somebody who you discover has rheumatoid arthritis, or you discover somebody who has antiphospholipid syndrome, that’s going to be a patient that you’re going to say, “Let me just involve the rheumatologist, let me involve some additional expert in this context,” but at least you’ve helped the patient because you’ve been able to add knowledge to what the actual problem was, you’ve made a diagnosis.
Dr. Aimee: Right. How do people work with you? Let’s say they’re not my patient and I haven’t referred them. How do they get onboarded with Pregmune? Can you talk to us about how that works?
Dr. Vidali: There’s a website, it’s very simple, Pregmune.com. Preg, like pregnancy, and then immune.
Dr. Aimee: That makes sense. Pregnancy and immunity, Pregmune.
Dr. Vidali: So, that’s the website, Pregmune.com. Ideally, your doctor has to order the tests, because that’s really the best way to do it, to be in direct communication with your doctor. I think that’s really the way to do it. We have ways because we have doctors in almost every state now the way we do it, and we can order it anyway and then you could take the report to your doctor, but I feel that the best way is to have a good rapport with your doctor. I think that’s really key.
I think one of the keys about your practice and what you do, Aimee, is that you listen to your patients, and you listen to your patient’s concerns. I think ultimately this form of communication is very important. To be able to communicate to your doctor and have a feeling that the doctor has listened to your concerns, I think that’s one of those things that are just there.
Dr. Aimee: Where do I order the labs from? Do I get a list, do you send it to me?
Dr. Vidali: It’s done for the patient. The labs go to Labcorp, which is a national level lab. Most of the labs. Only two labs go to another lab, which is part of Quest. So, it’s a national level lab.
I’d just like to mention the cost of this. There is a cost to labs anyway. If you go to any doctor and any doctor orders some of these tests, the insurance would be involved in paying for these labs. As any of us who have ever gone to the doctor know, the insurance says you have a co-pay, and a lot of it depends. The mysteries of health insurance. If you call the first time, they tell you no. If you call the second time, they tell you yes. If you call the third time, they tell you, “What is this?”
There are some issues sometimes with health insurance companies, but we work with the insurance companies to make sure that this is covered. Every blood test if you do not have insurance is expensive, but that’s the reality of any blood test. It doesn’t just deal with immunological testing.
Dr. Aimee: Let’s say I didn’t want to use my insurance at all, or I didn’t want to bother with it, or I have Kaiser or an HMO. What would be the out-of-pocket cost for the panel?
Dr. Vidali: First of all, Kaiser or HMOs may cover Labcorp, it is a national level lab. Sometimes you have to go to bat with the insurance companies, and we do that. Unfortunately, if you had to pay out of pocket, it would be about $5,000, which is a lot of money, if you have no insurance at all. It’s dramatic, and I understand that because it’s very painful for people not to be able to get the care that they need. We are working really hard with insurance companies to try to get a lower flat fee for this testing, but that’s the reality of insurability in this country, which is something that is very hard to fix, unfortunately.
Dr. Aimee: It really is. What do you see, as far as these levels and how it can impact a patient’s fertility? You mentioned it’s very science-based, and you have beautiful algorithms based on AI technology. Have you also then followed patients who have done the workup and then followed them forward as far as their success?
Dr. Vidali: The workup applies the science of reproductive immunology. It’s based on established science, so we do know what the impact of these treatments is on recurrent pregnancy loss or implantation failure.
Remember, we just launched. We’re going to have the ability to follow even more people prospectively and do even more studies and add to the existing evidence. Today, we’re working with the existing evidence of the treatment of reproductive immunology, which is established science, like we just said. It’s not like we are inventing something completely radically new. I just want to make it very clear that this is established science, this is something that exists and has been done for a long time. We’re just making it more accessible to people and also giving people information.
I think one of the big dilemmas for people is individuals who have had multiple pregnancy losses and now they have two embryos left. Two PGS embryos left, one embryo left, PGS test or no test, in any case, they have very few embryos left, they’ve done many retrievals, and they’re at a point where they’re going to say, “I’ve had seven or eight transfers, no implantation. What’s happening? What do we do at this point? Do we go the direction of surrogacy? Is surrogacy our only option?” These are very important decisions because there are moral, ethical, personal, financial, huge considerations at this point.
This is also an area where I think getting as much information as you can really helps. If you have done this testing and you’re in the lower prognostic area, this may help you make the decision to say maybe we’re going to forward and use a surrogate option. This is something that I deal with every day.
Dr. Aimee: Do you think we’re going to get to the point where we’re going to be doing HLA testing on embryos to help select better embryos to transfer? Not better, but you know what I mean, better matching embryos.
Dr. Vidali: I’ve done that. We have, in certain cases, done selective, specific types in HLA-C in embryos to transfer, but not enough to create a big scientific thing out of it. It’s not something I would necessarily recommend today. I don’t think the science is deep enough on this.
Also, one thing that we have to remember, and I think this is very important for any sort of intervention in medicine – as you know, I deal with a lot of endometriosis as well – interventions are often incremental. Whatever your number is, whatever you are, and then you’re adding to that with a certain treatment. This is an accepted concept, for example, in cancer. In cancer, they never look at specifically curing. They look at cure, but for them, cure is a very long disease-free survival. There is also curing of course, but most of the time they are looking at incremental improvements.
I think the same thing applies to fertility. You do these interventions which are incremental, and they take you from where you are to a higher level. It may not be 100% or 0. Unfortunately, the outcome can be 100% or 0, which can be extremely painful. We know that our patients have suffered, probably. It’s not the Olympics of suffering, but many of the patients that I’m sure you see, Aimee, have suffered the most because they’ve been through the most.
Dr. Aimee: Absolutely. By the time they get to us, they’ve gone through such tragedy that a lot of people can’t relate to if you haven’t had one-tenth of what they’ve experienced.
Dr. Vidali, thank you for your passion, thank you for what you’re doing. I really see that the platform you have built and created will, hopefully, change the minds of doctors as well, and it will make this field more accessible to fertility patients who just want someone to listen to their intuition. Thank you for all that you do. I know my patients adore you and they’re so grateful for you and the work that you do. I just wanted to say that. Thank you for coming on the show today and teaching us so much about this field and providing such great stories and anecdotes. Especially about that case at Columbia, that’s really wild.
Dr. Vidali: It’s true. You can look it up and you’ll find out about it.
Dr. Aimee: Before we sign off, is there anything else that you want to share with our audience members today?
Dr. Vidali: I always tell people this: never accept unexplained as a cause of your infertility or recurrent pregnancy loss. It’s my mantra. I think you’re owed a quest for an explanation. You may not get an answer, that’s the reality of it, but I just never accept unexplained as a first response to why things are not working out for you in anything.
Dr. Aimee: I tell people there is no such thing as unexplained, it’s just that no one explained it well enough. There are always possible explanations for every problem. I couldn’t agree with you more.
Thank you again. I hope you’ll join us again.
Dr. Vidali: Thank you. It was such a pleasure.
