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CONVERSATIONS AT CHR: Study on PRP for Ovarian Rejuvenation

Drs. Norbert Gleicher and David H. Barad discuss CHR's recent study on PRP (platelet-rich plasma) for ovarian rejuvenation, which could theoretically improve the function of the ovaries and help women with DOR conceive. CHR's study, which started in 2018, is ongoing.

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Hello, I'm Dr. Norbert Gleicher and I'm the Medical Director of CHR. And I'm pleased to be here with my colleague and friend, Dr. David Barad who is running our Assisted Reproduction Program. We are here today to discuss a subject which is getting increasing attention from the public and also from the media and that is (what is in popular lingo called) "ovarian rejuvenation," but we here at CHR like to call PRP (or platelet-rich plasma injections into the ovary). Because, frankly, I think I'm correct when I'm saying that nobody knows whether we really are rejuvenating the ovary as of this point, at least this is a treatment that has come into medicine probably roughly a decade ago, and at least in the very beginning was highly controversial. It initially started in sports medicine, and if I remember correctly, some of the first practitioners who injected PRP into the joints of some of the country's most prominent athletes almost lost their licenses over doing so. But, it proved to be very effective in improving inflammation in joints. It became very popular and effective in various autoimmune and rheumatological diseases. It is now widely used in plastics and it has become a very popular treatment for hair regrowth (which neither of us has tried). Which neither of us has tried, exactly... yet! So, European colleagues in Greece were the first ones to try the injection of this PRP into the ovaries in cases of premature ovarian menopause, or as it is called, "primary ovarian failure." And, even though they reported early success, no studies were forthcoming. And that's when we decided it was time and to do such a study because we, frankly, felt that there was a good theoretical, hypothetical background for thinking that this may work, yet at the same time, without anybody publishing any hard data, we were not willing to proceed. So, at that point, we started the study and I think maybe you go on and explain a little bit what we did from that point on. So, to be fair, the Greek folks have published an abstract which described some response, but they have very little follow-up, although they now have probably a four or five-year experience. There was one other publication from a group in California, which again reported on the outcome of their first few patients and showed that they had had an ovulatory response, and were able to go through an IVF cycle. We decided to look at this carefully and people in the past have opined that you could see an effect from this kind of treatment for up to six months. And, the previous studies out there are relatively uncontrolled and just observational and it's impossible to know whether any outcome that they have observed within six months is because of treatment or something might have happened (accidentally) anyway. We've all had the experience of taking care of women who were perimenopausal who occasionally ovulate anyway. Exactly. So, we've divided our patients into two groups-- those people who were dealing with age-related fertility problems and we've offered them to use the PRP. In that case, we're actually injecting both ovaries and observing them over time, similar in the way to others have, but I think maybe a little bit more organized and controlled. And, we're looking more carefully, and we've especially focused over the first two or three months after the patients have been treated. The second group I think you'll find more interesting because in that group, we're randomly injecting one ovary, and these are in people who are younger than 40 who've lost their menstrual function often times for years. And, we're only injecting one ovary and then we're following them (also very closely). And the endpoint of that study will be to see if the ovary that we've injected is the ovary that responds. The process is pretty simple. PRP is just platelet-rich plasma, as Dr. Gleicher said. It's just a question of taking a patient's own blood sample, spinning it down, concentrating the platelets into a small pellet, and re-suspending them in some of their serum, and then we inject the outer cortex of the ovary (which is where we hope follicles might develop). That's done under anesthesia, it takes a few minutes, and then, the hard part is following them very closely for the next two or three months. And, it is important, I think, to re-emphasize the point that this is a product that comes from the patient's own blood. And, therefore, it is what we medically call "autologous" and has no risks of causing an immune reaction, has no risks of infection since we deal with it in a sterile fashion. It's collected in what we call a "closed system," which means once it's collected, the sterile contents are not touched again, they're centrifuged within the sterile container, and then removed with the sterile syringe and injected into the ovary. And, it is actually also important and interesting to understand that how this is done is almost the reverse of an egg retrieval during a regular IVF cycle. In other words, we're using exactly the same setup, the same needles (with which were usually aspirate fluid and the eggs from a patient), by now injecting fluid into the ovaries. So, the anesthesia (which is really only intravenous sedation) is the same as in an egg retrieval and all the instrumentation we use is also the same as the patient will have if we succeed, and if we get an egg growing, and if we can retrieve an egg, then in an IVF cycle. Our trial is basically only there to determine whether we see in patients (who previously did not have the ability to produce follicles that we can see in ultrasound), we suddenly now start seeing them having growing follicles. At that point, our trial ends. So, maybe explain a little bit where it goes from there? Yes, so the patients in the trial are people who essentially have experienced menopause even though they're only in their late 20s-30s. They haven't had periods for many years. When you look at these ovaries, they're hard to find. They're small. They have no follicles in them. We followed them closely for the first two months, every week doing an ultrasound to see if any follicles have shown up, and we measure their hormones. The observation of a follicle larger than four millimeters and rising estrogen signifies the endpoint of the trial. At that point, the patient, or the participant, has the opportunity of becoming a patient and entering an IVF cycle or at least an attempted ovulation induction. We would give fertility medications and try to help that follicle to grow. If it grows and the estrogen rises, we would, in some cases, take them to egg retrieval and then hopefully an embryo transfer. And this is, actually, a difference in how our trial works in comparison to what some colleagues are doing who also use PRP and do just observational studies because they, in principle, do not follow those patients with ultrasounds. Their main guide are the hormone levels. And, hormone levels are important because they tell us whether what we see on ultrasound is growing. But, in the end, it is much more dramatic, as a piece of evidence, when you have a patient who for months or years never had a follicle on her ovaries, and suddenly we see a follicle (even if it is small) as growing. And, so, it's important to understand that this is a big difference in how we designed this study because it indeed gives the patient an opportunity to have an egg and have an embryo. And, as we will be talking about it in a moment, we have seen some patients where we have been able to retrieve eggs and produce embryos. This is a crucially important point because if you follow patients (as most of our colleagues do) only with hormones, you may not have enough support nutrition for that little follicle that is growing. Yeah, you may see a little rise in your estradiol level, but then the follicle dies and the cycle is over. Here, we have the opportunity to jump in and start stimulating and give more nutrition. Our experience (which has been going on for a long time) of taking care of patients who have problems with their ovarian function, is that these people, their follicles, will go on to what we call "rapid atresia," meaning the follicle can no longer support the development of the egg. So, if you see a follicle and you wait a week before you do anything, you're not likely to be able to have very much success from that follicle. So, we're trying to pick these things up as soon as they show up, and then try to jump on and try to support it. So, let me also start talking or bringing into this discussion our observational study because I think, there too, we are doing things that haven't been done before and are quite important for patient care. This is a study in usually quite old patients, and I think it's also important to note that this tool is actually a carefully selected study because those are older patients where usually everything else hasn't worked, and they have not produced follicles. And that is, again, an important point because we follow these patients also in the same way, and we supplement those patients, too. In other words, once we see a follicle grow, the study stops and the treatment starts with the same rationale behind it. And, in those older patients, we also have seen already some pretty remarkable results and not six months down the road, but actually surprisingly early. The interesting thing is the close interval from the time of treatment to the time of the response, which I think is significant. It makes it more likely that it's a causal [factor] in that situation. Yeah, that is absolutely true. So, let's talk a little bit about why this study isn't over yet, even though we started it almost a year ago. Maybe you can explain to the audience how a study is conceived and how you predict how many patients you have to enter into a study before you start the study. Yeah, so in terms of designing a study, as Dr. Gleicher said, you have to make an estimate of how many people you would need to study to have confidence in the observations-- do they mean anything? For example, if you had two patients and both happen to respond to your treatment, that doesn't prove that the treatment is successful. If you close the study after two people, it doesn't mean anything because it could be the next two people don't respond to it. Or, the next ten people, even though we have a saying that everything works in the first, maybe second patient. So, we began with the plan of recruiting, I think, 40 patients. And, the people we are trying to recruit to the trial, who've lost their normal menstrual function before the age of 40, are not very commonly found. Less than 1% of women are in this kind of category, and I think it's remarkable that we've been able to recruit the 16 or so already. Right, actually, only 16 have gone through it, but we have recruited even more. So, we do expect to complete our recruitment within the next year or so. But, for us to talk about the results at this point (even if they look good at this point) doesn't mean that it will hold water at the end of the day. That is very important and I think that is also may be a very good concluding remark, re-emphasizing that one of the things that we are proud of at the Center for Human Reproduction, that while we are trying to bring new treatments into the infertility field, and have been very successful in doing so, we're trying to do it on evidence, with an evidence-based approach. In other words. we are not making claims that we cannot support. We are very transparent with our patients in telling them that we don't know, we are trying, we're investigating. And, hopefully, at the end of that process, we will have an answer. And then we let our colleagues know through our publications, and hopefully, they can apply what works as well. Thank you very much for watching us and if you have any questions, you know where you can reach us. We'll update you as the study progresses and we get conclusions. Great point, thank you.

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