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Ovarian Rejuvenation Study: Using PRP (Platelet-Rich Plasma) to treat Premature Ovarian Failure
Dr. David Barad explains CHR's Platelet-Rich Plasma (PRP) clinical trial in New York City: https://goo.gl/92bZbG In this video, he explains the qualifications for participating in the trial, the procedure itself, monitoring post-procedure, and more. Additionally, women who do not qualify for the study can undergo PRP outside of the trial. Contact CHR online or call us at (212) 994-4400 or (212) 933-5700 for more information.Want to Consult Dr. Barad?
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1% of women experience loss of normal menstrual function before their fortieth year. This is called premature ovarian failure. For the most, part women with this problem are very unresponsive to any normal approach to trying to help their fertility. There are cases of sporadic pregnancies and you can have premature ovarian failure and still occasionally have a period (still even occasionally ovulate), but the point is that you don't have regular menses. In fact, I think you have to have at least four months of amenorrhea to be considered as a person with premature ovarian failure. So patients are frustrated by this experience, and we as physicians are frustrated at having nothing really to help them. Recently some new approaches to dealing with this problem have become available. Platelet-rich plasma is an approach that's been used in many areas of medicine to try to so-called "rejuvenate" tissues. Platelets are very small components in their blood that normally help with clotting, but they are rich in growth factors and cytokines. These are in little granules within the platelets and when you use platelet-rich plasma the goal is to release these cytokines and growth factors into the tissue, which then help the tissue to regenerate. Under normal circumstances as tissue gets old, it gets replaced by fibrotic-- basically scar tissue. What happens as ovaries age is that they become like little clumps of scar tissue. In using platelet-rich plasma our hope is that we can regenerate some of the normal ovarian tissue and not just that but regenerate vascularization, so there's improved blood supply, and as a result hopefully restore some ovarian function. Platelet-rich plasma--which I'll call PRP from here on in-- has been used as I said in other fields, but it's begun to be used in the fields of infertility as well. However up until this time, there haven't been any well organized research trials to see if it really makes a difference. As I said earlier, some people with premature ovarian failure continue to ovulate and occasionally even get pregnant on their own, so unless you have a controlled situation, you don't really have a way of knowing whether your intervention (in this case Platelet-rich plasma PRP) is really being effective. So while we hope that PRP could be helpful for anybody with problems of ovarian function, our goal for this study is to restrict treatment to women who truly have premature ovarian failure. If in this controlled setting we can show that we can help this worst case scenario, then our expectation is that it will also be helpful for other people. Therefore to be qualified for this study, you have to have premature ovarian failure. The first major qualification therefore is that you be 40 years of age or younger. Secondly, that you have an FSH-- the follicle stimulating hormone-- that would be consistent with somebody who's achieved menopause (meaning greater than 40). Thirdly, on the ultrasound examination of your ovaries, there should be no follicles that are greater than 4 millimeters in diameter. If there were, that would mean you were still producing follicles on their own and you know may not need the PRP treatment. In restricting our study population to this truly disadvantaged group, we hope to be able to see if the PRP Is truly effective in people who truly have a problem and wouldn't be expected to have normal ovarian function on their own. Whether you're qualified or not therefore is is kind of simple. It involves some laboratory testing and some things that you already know you know-- how old you are (so you need to be 40 years or less). The laboratory testing that we'd like you to have before your initial consultation to make sure if you're qualified for the study at this point is simply a serum FSH test --which many of you have have already. We'd also like you to have a karyotype. A karyotype is an examination of your chromosomes and we'd rather not have people in the study who have a known genetic cause of a failure of their ovarian function-- for instance Turner syndrome or something like that. So most women with premature ovarian failure will have amenorrhea. So in terms of timing treatment and timing what we're doing, we don't have to match it to any particular cycle. After your initial consultation-- once we know that you've qualified for the study, we'll ask you to sign a consent. We'll draw some blood and we'll do an ultrasound examination just to confirm of some of the things about you (to make sure you're qualified). We'll also ask you to fill out a few pages of study forms--giving us some background basic information, and then we'll try to schedule you for the procedure. For the procedure itself, the first step will be preparing the platelet-rich plasma. For that you'll come to our office on the morning-- Early in the morning that we're going to do this procedure, and we'll draw probably about 20 milliliters of blood (that's approximately two of the large red top tubes that you might be used to having your blood drawn in). That material will then be processed by the laboratory and the lab will extract from that about one milliliter of this platelet-rich plasma. That process will take a couple of hours in the laboratory-- during which time you can relax, but you won't be able to eat because later in the day we'll be giving you anesthesia, so you'll need to come in not having eaten and unfortunately starving a bit through the morning until the procedure. The procedure itself will be scheduled later in the morning after the PRP has been prepared. We, within the study, will be injecting PRP into only one of your ovaries. Now which ovary is injected (the right or the left ovary) will be randomly selected after you're already put under anesthesia in the O.R. The doctor will then use a needle (similar to the needle that we normally use for an egg retrieval-- it's a very thin needle actually smaller than what we've normally would use to draw blood but relatively long so we can reach back into your ovary). We, using ultrasound to visualize your ovary, will inject about one cc of this PRP of prepared material into your ovary not as one major bolus in one spot, but as little sort of tattooing motions along the surface of the ovary so we can distribute the material in a larger area across the ovary. Following this you don't wake up, we actually won't tell you which ovary that we've injected. It'll be recorded in our study chart, and then as we go forward over the next few weeks, we will be comparing the one ovary to the other to see whether follicles begin to emerge in one of versus the other. And that's how the study is going to be controlled. After the procedure we want to follow you fairly intensely. So for the first two weeks after your PRP procedure, we'll be following you every three days and at each of those visits we'll require a sonogram and a blood test. On the blood test we'll be looking at your estrogen level and your FSH level and that will help us see or give us a heads up if your ovary is responding. And each of your visits, we'll be looking at both your ovaries and looking to see if there is the emergence of a follicle that's larger than four millimeters (that would be a normal early antral follicle). After the first two weeks if we haven't yet seen a response, we'll continue to follow you weekly, with the same kind of observation and we'd like to be able to continue to follow you up to 12 weeks, so there'd be several continued visits to see if there's any kind of response. We do not know yet how long it might take for you to respond, and that's why we've got this long tail for follow-up of this study. At any point that we see a response, that we see evidence of the estrogen rising, of a follicle appearing and possibly growing larger than four millimeters, your participation in the study will have ended. At that point you would have the option of entering a treatment cycle in which we would supplement the follicles growth with some fertility medications, and then follow you along and do an egg retrieval when the follicle appears and when the follicle and estradiol have risen to the point that they appear to be viable. In this case it might be when the follicle is just about 14 millimeters because our experience with women who have decreased ovarian function has taught us that we do better retrieving eggs at relatively smaller follicle size. But again, that would be in within a treatment cycle and there would be costs and procedures that would normally occur in an IVF cycle. As I said earlier, true premature ovarian failure is very uncommon. Yet, we see many women who have ovaries that are not really working at top-notch function. These women, although they may not qualify for the study, may indeed choose to have PRP treatment. At this time we truly don't know whether that's a useful intervention or not, but we're willing to administer it on a somewhat experimental basis-- although this would not be a controlled experiment. Since this is not within the context of a trial, there would be charges associated with preparing and administering the PRP and since it's not within the trial, you would have the option of having both ovaries injected with the PRP material. Your experience of that would be similar to that of the people in the trial-- in that you would also come in in the morning, we would prepare the PRP, we would need more blood to prepare PRP for two ovaries than within the trial (probably 20 CCS for each ovary) and we would prepare the material, and later in the day you would have anesthesia and we would do the same sort of procedure but on each ovary, you would recover from the anesthesia, and we would also like to follow you closely for the first two weeks and twelve weeks afterwards in the same way that we're following the people that are in the trial, so that we can discover how you're responding and treat you accordingly. Now so that you're not in a trial your treatment will be individualized according to your own physicians opinion and you may be supplemented with other material, other fertility medications (perhaps growth hormone) and we would hope to see some sort of response. So, here at CHR we're privileged to take care of many women who have major problems in the way that their ovaries function and we're gratified=that people put their trust in us to try to move this forward. As we're working sort of on the edge of our understanding of how these ovaries work and what we can do to try to help them, there's a degree of uncertainty about you know whether this particular treatment is going to be reliable or not and we appreciate people who have that trust in us and are willing to try something and together we can learn and hopefully advance the field. To get started, if you're interested in participating, if you're already our patient, we've already probably already done much of the basic workup, and it'd just be a question of calling in for a follow-up, and we'd organize the data that we have and talk to you about the study in more detail, ask you to sign consent, and we go forward. If you're not already a patient at CHR we'd ask you to collect the information you have from your previous medical doctors. If you have a previous karyotype study of your chromosomes, that'd be convenient. If you haven't, you could ask a physician to draw one before coming to see us. It normally takes several weeks to get a karyotype back, so if you come to us and have not yet had it done, it would delay anything going forward until maybe three to four weeks after your initial consultation, so the sooner you get that test the better off you are. And of course you can have an FSH test done at that time too. Come in with those results and your previous medical records and and then that would expedite deciding if you qualify for the study and helping us to move you forward.
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