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Uterus Transplant Cost, Candidacy, & Screening Process

Author Taylor Spurgeon-Hess covers Uterus Transplant Cost, Candidacy, & Screening Process on BackTable OBGYN

Taylor Spurgeon-Hess • May 24, 2023 • 1.4k hits

Clinicians find themselves at the forefront of a revolution in reproductive medicine with the emergence of uterus transplants. Dr. Elliot Richards, Director of Research for the Division of Reproductive Endocrinology and Infertility at the Cleveland Clinic, delves into uterus transplant costs, the history, candidacy considerations, & screening processes of this groundbreaking procedure, shedding light on the transformation of skepticism into success. By understanding the evolution and technical aspects of uterine transplants, clinicians can navigate the complexities of this procedure and explore its potential to empower individuals facing infertility in their journey toward parenthood.

This article features excerpts from the BackTable OBGYN Podcast. We’ve provided the highlight reel in this article, and you can listen to the full podcast below.

The BackTable OBGYN Brief

• The first uterus transplant was attempted almost 100 years ago, despite the lack of immunosuppressants or established transplant techniques. The modern era of uterus transplantation began with a systematic approach by Mats Brännström's Swedish group in 2013, resulting in the first successful live birth from a transplanted uterus in 2014.

• While the uterus transplant procedure was originally developed for cisgender women unable to bear children, there is growing interest in offering uterus transplantation for gender-diverse and transgender individuals.

• A significant portion of the uterus transplantation process involves the patient’s psychological readiness and understanding of the potential risks and benefits, including the requirement for immunosuppressants.

• Infertility is not universally recognized as a disease, leading to a lack of insurance coverage and funding for treatments in many areas. However, a diagnosis of infertility has been shown to create the same levels of stress and anxiety in patients with a chronic condition or cancer.

• Even though uterus transplant cost is high, it has already been sought by numerous potential patients, indicating a significant demand. Most of the current recipients are those with Mullerian agenesis, but there is a wide range of other conditions leading to infertility.

• The screening process assessed patients’ willingness to undergo anesthesia, IVF, major surgery, high-risk pregnancy, and high-dose immunosuppressive therapy. Additionally, medical history was extensively reviewed with factors such as BMI, history of cancer, hypertension, diabetes, hepatitis, HIV, and the presence of pelvic kidney influencing candidacy.

Uterus Transplant Cost, Candidacy, & Screening Process

Table of Contents

(1) Uterus Transplant History & Evolution

(2) Recognizing Infertility as a Disease

(3) Uterine Transplant Cost & Candidacy

(4) The Screening Process for Uterine Transplant Candidates

Uterus Transplant History & Evolution

While initially greeted with skepticism by many clinicians, the world of uterine transplants has been transformed through the dedication, persistence, and innovative thinking of pioneering surgeons and patient advocates. Often patient-driven, the quest for this life-altering procedure has been primarily motivated by women unable to carry a pregnancy, along with gender-diverse individuals seeking more comprehensive gender-affirming surgeries. Mats Brännström, a key figure in the development of modern uterine transplants, practiced meticulously on animal models to ensure a systematic and careful approach to this procedure in humans, yielding the first successful birth via a transplanted uterus in 2014. However, the first attempts at this challenging transplant can be traced back to the early 20th century. In light of global restrictions on surrogacy, uterine transplants offer a promising alternative to child-bearing, yet also face ongoing challenges such as cost, technical difficulty, and need for immunosuppression.

[Dr. Mark Hoffman]
You mentioned Mats Brännström. I remember I went to AGL one year. I think he was one of the keynote speakers. I remember being, honestly, a little confused, like, why do we need uterine transplant? At Mayo, it was obviously not part of my practice as a mix surgeon. Talk to us first about the history of uterine transplant and with that, maybe a touch on why it was started, why it's being done.

[Dr. Elliott Richards]
It's really fascinating. When you talk with the early pioneers including Mats, they had the same reaction and actually, like, why uterus transplant? That's crazy. Mats, he could certainly should speak for himself, and if you ever had the opportunity to chat with him, but my impressions from conversations with him, I got to hang out with him actually at the international conference just last fall, and was able to get the story again from him. It really was uterus transplantation in the modern era has been patient-driven and patient demand.

His story, as I understand it, truly was a patient saying, "Why can't we do this? Why can't we do uterus transplant for me?" His reaction first was like, "That's crazy." Then, as he thought about it more-- and it's been a similar story, I think, for all the early pioneers. First time hearing it being like, "This seems absolutely ridiculous," but as you learn more about the patients, and also the process, it begins to make a lot more sense. One of the goals that I have for our talk today is I hope to convince some of your more skeptical listeners that this is actually something that we should take seriously.

[Dr. Mark Hoffman]
I think he also mentioned that where he's from, it's illegal, surrogacy is illegal. I know that in the state of Kentucky, actually, surrogacy is illegal. We always think, "Oh, why don't you just throw that embryo in somebody else's uterus?" If that uterus is still in that person, in many places in the world, that's not an option. Certainly, patients have the opportunity and the autonomy to make decisions for themselves. Uterine transplants, an interesting topic, but it's also the only option for some patients as well. It's not been around very long. This is not something people have been doing for a very long time.



[Dr. Elliott Richards]
Correct. In the '50s and '60s, there were a series of animal experiments, mostly autotransplantation, first in dogs and then in primates, removing the uterus and putting it back into the same animal. To my knowledge, there was no demonstrated pregnancies at that time. The first in the modern era uterus transplant was actually in 2000. That was in Saudi Arabia. It was a living donor. There's graft failure at about three months attributed to a thromboembolism.

Then in 2011, in Turkey, there was a deceased donor of uterus transplant that was performed by a plastic surgeon. Interestingly enough, that patient delivered just about two years ago, and so she was on immunosuppression for almost a decade. It was actually Mats Brännström who partnered with them to troubleshoot. They did some revisions of the graft, and that's thought to be the reason why they were able to ultimately achieve pregnancy. I think what's important about the Saudi Arabia and the Turkish case is that these were not done in clinical trials. They were one-offs.

The reason that the Swedish group are really considered the pioneers is they really took a systematic approach to uterus transplantation, actually starting with their own animal experiments. The first animal study showing successful pregnancy was actually in a mouse model in 2010 by Mats Brännström's group. I think Mats recognized that a big failure would set back the field, potentially even indefinitely. They were really very careful and approached it very cautiously. Unlike, unfortunately, these two first attempts that were really just, again, one-offs and, "Hey, let's just do it because we can." What I consider the modern era of uterus transplantation truly began with the Swedish group, with their clinical trial in 2013, and then their successful live birth a year later in 2014.



[Dr. Amy Park]
I have to admit, when I first heard about uterine transplant, I was like, "Who would want to do that?" Like, "Just get a surrogate." Obviously, when you're on protocol, there's not as much cost to the patient, but it's a huge surgery. We're talking about grafts, we're talking about immunosuppressants. Just hearing about it and the sheer technical aspect and psychological aspects. Also, I have to give the pioneering surgeon so much credit because patients try and push us into things all the time. You have to be really open-minded in entertaining these seemingly impossible endeavors and that can-do spirit. Then saying, "Why not," instead of, "Why," or trying to come from a place of, "Yes." I really do have to respect that.

Listen to the Full Podcast

Uterine Transplant with Dr. Elliott Richards on the BackTable OBGYN Podcast)
Ep 20 Uterine Transplant with Dr. Elliott Richards
00:00 / 01:04

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Recognizing Infertility as a Disease

Historically, the groundbreaking progress in the field of uterine transplantation, often compared to early attitudes toward kidney and liver transplants, has been met with skepticism. Yet, as Dr. Elliott Richards points out, acknowledging infertility as a disease is a significant step toward recognizing the importance of uterus transplants. Despite ongoing ethical debates and varying societal attitudes towards fertility, the disease classification is crucial for those suffering from this form of infertility, which was previously deemed incurable. Moreover, the psychological burden of infertility, comparable to a chronic condition or even cancer, emphasizes the urgency for its recognition and treatment. This paradigm shift not only addresses the current lack of funding and insurance coverage for infertility treatments in many regions, but also promotes a more inclusive perspective towards family building in societies worldwide.

[Dr. Elliott Richards]
The first generation of kidney transplant surgeons who worked with Dr. Starzl, a lot of them are around still. It's so interesting. In fact, one of them, Dr. Zahka at Cleveland Clinic, I definitely want to give credit to him. He was really the person who brought it to the clinic. He was involved in Dr. Brännström's some of the uterus transplants in humans that were performed. He was a trainee of Dr. Starzl, really, the pioneer in transplant surgery. As he tells it, a lot of the same attitudes that are about uterus transplant now were the same things were being said about kidney transplant and liver transplant in those early days. I think, ultimately, because there are a lot of naysayers, and I think that this is not a clear cut issue, there's a lot of complexity here and ethical questions to ask. These ethical questions actually have been debated and talked about for actually decades at this point.

Any concerns or points that people bring up either for or against uterus transplant, I can guarantee you that they've pretty much been talked about in depth. I think the fundamental question for me is, do you consider infertility a disease? That's something that ASRM and RESOLVE, which is advocacy group in the United States for infertility, really, that classification is important, because once we recognize and accept the idea of infertility being a disease and something that warrants treatment, we suddenly have this population who have what before was essentially incurable form of the disease, and now we have a treatment for it. I think, fundamentally, a lot of people who are against uterus transplant, there is, not always, but oftentimes, a resistance to this underlying concept of infertility being a disease.

[Dr. Mark Hoffman]
I've seen that in training along the way. I trained in Illinois, where insurance covers female infertility, and then Ann Arbor, Michigan and back here in Kentucky, where infertility's not, in a sense, treated like a disease. If it's a disease, you would think health insurance should recognize it for that, and there should be a treatment for it, which it is a diagnosis. There is an ICD code and we do have CPT codes for the procedures we do for these things, but it's not considered a disease by the institutions who we've charged, in a sense, for paying for management of those diseases.

[Dr. Elliott Richards]
Absolutely. I think that, as you say, sometimes there's lip service given to it, but absolutely, is not being seen as the disease that it is. One point that I wanted to make is that it's been known ever since the '90s, actually, that a diagnosis of infertility has the same stress and anxiety level on patients who suffer from infertility as a cancer or other diagnosis of a chronic condition. There's a massive impact on a person's wellbeing and mental health by having an infertility diagnosis. One of the rotations I was able to do as a Mayo Clinic resident was to go to Uganda and work in a Ugandan hospital. It was so fascinating to me because there is amazing amounts of money flowing into Africa to help support family planning, which of course, is a euphemism not for necessarily building families, but for contraception birth control. Those are definitely very important things to give.

So many women who are ostracized, the level of isolation that they felt and the loss of their social status was akin to fistula, which gets a lot of attention in Africa, but yet as I shadowed this brilliant Ugandan gynecologist, his clinic was like, I don't know the exact numbers, but certainly felt like 75% infertility. Patients coming from all over rural Uganda because there just simply is no money towards family building because the emphasis is so much on contraception. I think we see something similar here that, United States, which has such lip service towards family values and family building. There's gross lack of funding and insurance coverage for fertility and conditions that cause infertility.

Uterine Transplant Cost & Candidacy

Uterus transplant cost is estimated at around $200,000 to $250,000, but it includes IVF, pregnancy, and delivery, making it a comprehensive package. It has evolved from an experimental treatment to a potential gold standard solution for Absolute Uterine Factor Infertility (AUFI), which profoundly changes the prospects for those affected. It has been primarily offered to patients with Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome, also called Mullerian agenesis, despite the fact that this condition makes up only a fraction of the infertile population. As the treatment's success becomes increasingly evident, there's a pressing need to expand access and offer it to a broader range of patients. This includes the many women who have undergone a hysterectomy and may wish to carry their own child. While the task is immense, the demand is clear, with patients actively seeking this transformative treatment despite minimal advertising.

[Dr. Mark Hoffman]
When it comes to uterine transplant though, and this is something that, again, I think, certainly, in doing some homework for this, it's not something I learned about in residency because it was something that was being done with any regularity when I was in residency. Can you walk us through the process in terms of patient selection? Who is a candidate for uterine transplant? How are we deciding who gets them, et cetera? All the way through a pregnancy. Can you do that in a way that won't waste your whole night with it? I'm sure it's a very simple process.

[Dr. Elliott Richards]
Can I do it in a way that's concise? Yes, absolutely. Let me back up just a second though, and say that uterine transplant is an interesting time, in that, it is beginning to transition from experimental science to really a curative treatment that is on its way to being, potentially, a gold standard care for patients with absolute uterine factor infertility. In fact, the group in Dallas now has a cash pay uterus transplantation that's outside of a clinical trial. They've had three patients who have paid for uterus transplantation. University of Alabama now, they started a trial of, I believe, they're funded for 25 uterus transplants, and they elected not to do it under a clinical trial. This change is happening. Now, for us at Cleveland Clinic and at Penn, both of our centers are still doing this work through a clinical trial, but this transition is happening. It's happening because the efficacy truly has been established.

[Dr. Amy Park]
By the way, how much is the uterus transplant cost? How much are they charging?

[Dr. Elliott Richards]
It'd be great if we had Lisa Johansen on the call to speak. I believe, it's on the ballpark of around 200,000, might be 250,000. I believe that covers IVF and the pregnancy and delivery, so it's like a full package, but don't quote me. This is my understanding of the rough estimates. I'm not answering the question you first asked, but that's a big thing that our centers are working on. One thing just as another aside, it's really so wonderful being in uterus transplantation, is that it's incredibly collaborative between us, the Baylor group, the UAB group, and Penn, where we're sharing data, we're sharing things that we've learned. That's one of the things that we're working on now, is cost-effectiveness analysis. We're building some models and we hope to publish in the next year, but there's going to be some arguments that can be made especially for patients who want more than one child.

That even putting aside the lack of access to just, say, for surrogacy for a lot of people in different states, and certainly, European countries, but there may even be some economic arguments for uterus transplantation. That's getting off-topic for what you asked. In terms of walking through the whole process, I also want to say it's important to recognize who this is for. I was mentioning, setting the stage, talking about it being under the guise first of clinical research because the patients who have gone through and gotten uterus transplant, and I should say, we have over 31 babies born at this point in the United States. The vast majority of patients who have gone through, they have been Mayer-Rokitansky-Küster-Hauser or Mullerian agenesis patients, vast majority. When we look at the 5,000 people who have contacted our three centers, meaning Penn, Baylor and Cleveland Clinic, that's actually only about 20% of the applicants. Because this has really started out as a clinical research trial, we've really selected the best prognosis patients, but this doesn't reflect the actual true population that suffers from AUFI, Absolute Uterine Factor Infertility.

There's huge problems with disparities that these are most often White women, and that's not a reflection of the patients who are suffering. Particularly when you look at secondary AUFI, hysterectomy. It's estimated that as high as 15% of reproductive-age women have had a hysterectomy. We're talking, potentially, hundreds of thousands of women who might-- Of course, that doesn't mean they're all interested in carrying their own child and taking on the risks of uterus transplantation. Potentially, a huge population in the United States that might be interested. Really, it's been just a very small subset. In terms of our trial and who's selected, they go through an extremely rigorous process. With the thousands of people who have contacted our center, we've really only selected, essentially, a dozen women to be recipient candidates. The hope and goal has always been to expand access to this treatment to more women.



[Dr. Elliott Richards]
Certainly, there was marketing and reaching out to media outlets, and so I'm not going to say there was no-- Definitely, no direct advertising, but there's definitely exposure. Beyond that, we essentially closed off our trial because we found all of our candidates relatively quickly and we still got, again, no advertising, just people finding ClinicalTrials.gov, the email address on there, and just getting hundreds and hundreds of people contacting us.

There is a lot of demand here. I think, while I'm talking about this one particular woman, and she was actually our first successful live birth, her story is, I think, so fascinating because she actually had a child through gestational surrogacy, and it was such an awful experience for her because she had such a loss of control and reproductive autonomy with what the surrogate was doing and all that goes behind that, that she wanted a second child but absolutely did not want to do gestational surrogacy again. Even though it was an option and something that she had tried before, she looked at all the risks and the unknowns, particularly at that time when she was admitted to the trial and said, "This is important enough to me and I don't want to go back to using a surrogate again."

The Screening Process for Uterine Transplant Candidates

The selection of candidates for uterine transplant is a rigorous process, informed by stringent criteria set in the early stages of clinical trials. These trials demanded comprehensive screening of potential candidates, involving a multi-disciplinary team of ethicists, social workers, and psychologists. To be eligible, candidates had to demonstrate a readiness to undergo anesthesia, in-vitro fertilization (IVF), major surgery, a high-risk pregnancy, and to receive high-dose immunosuppressive therapy and vaccinations. An integral part of this process was the patient's capacity for informed consent, which demanded a high level of understanding about the procedure, its risks, and potential outcomes. Medical history was carefully scrutinized, with factors such as BMI, history of cancer, hypertension, diabetes, hepatitis, HIV, and the presence of pelvic kidney influencing eligibility. Single women were not excluded if they had sufficient social support. This intricate selection process was deemed necessary to ensure the best possible outcomes for these pioneering transplants.

[Dr. Amy Park]
They have this surrogate and she's doing all the things that just make your toes curl. She's drinking, she's smoking, she's partying, she's carrying the fetus. What in particular makes somebody a good candidate to undergo the surgery? I'm assuming there's physical components, there's psychosocial support, there's all sorts of things, stable relationship. I don't know, I'm not sure. Do you say it's okay for a single woman to undergo this? I don't know.

[Dr. Elliott Richards]
Again, I can only speak for our clinical trial in terms of our screening criteria, which, because we really designed our trial as one of the very first in the world, by necessity, it was a lot more stringent inclusion criteria with the hope that we can expand access as efficacy is shown, and moving on to, potentially, more complex presentations in patients.

There's first of all, in the screening process, a lot of experts that they need to meet with. All of our candidates met with ethicists, with social workers, with psychologists. They needed to be willing to undergo anesthesia. IVF, a major surgery, a high-risk pregnancy and really multiple surgeries. They need to be willing to receive the high-dose immunosuppressive therapy, to receive vaccinations, and informed consent.

What is informed consent? How can you truly consent anyone? There needed to be high level of understanding and education for these patients so they knew what they were signing up for, particularly at the beginning when we didn't really know how successful this was going to be, because we really only had the first Swedish trial to go on. Very extensive screening into their medical history. We had a BMI cutoff. A lot of these patients, again, Mullerian agenesis, and so we would exclude patients if they had a pelvic kidney, for example, if there's any history of cancer for the exception of early-stage cervical cancer, any history of hypertension, diabetes, hepatitis, HIV. With our clinical trial, cisgender women, we did not, and it was actually a big area of discussion at the beginning in terms of will we allow single women versus do they need to be in a relationship. Ultimately, we decided it was important that they had social supports, but they didn't necessarily need to have a partner or be married. We felt that that was just discriminatory, and obviously, some discrimination on the basis of medical criteria we had to have just because it was early trial, but that social sort of discrimination was deemed to be not a compelling argument to exclude those women.

Podcast Contributors

Dr. Elliott Richards discusses Uterine Transplant on the BackTable 20 Podcast

Dr. Elliott Richards

Dr. Elliot Richards is the Director of Research in the Department of Reproductive Endocrinology and Infertility at the Cleveland Clinic.

Dr. Amy Park discusses Uterine Transplant on the BackTable 20 Podcast

Dr. Amy Park

Dr. Amy Park is the Section Head of Female Pelvic Medicine & Reconstructive Surgery at the Cleveland Clinic, and a co-host of the BackTable OBGYN Podcast.

Dr. Mark Hoffman discusses Uterine Transplant on the BackTable 20 Podcast

Dr. Mark Hoffman

Dr. Mark Hoffman is a minimally invasive gynecologic surgeon at the University of Kentucky.

Cite This Podcast

BackTable, LLC (Producer). (2023, April 6). Ep. 20 – Uterine Transplant [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.

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