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Platelet-rich plasma (PRP): 3 ongoing trials at CHR

Posted on Mar 13, 2020

Platelet-rich plasma (PRP) entered the medical field in the 1970 when hematologists discovered this plasma fraction that demonstrates higher platelet counts than peripheral blood. It was initially used as a transfusion medium to deliver platelets to patients who needed them, mostly women with thrombocytopenia (low platelet counts). It was then appropriated by maxillofacial surgeons in combination with fibrin, as so-called platelet-rich fibrin (PRF) since fibrin enhanced adherence and had homeostatic properties, while PRP was recognized to have anti-inflammatory properties and, in addition, stimulated cell proliferation and, therefore, healing.

PRP’s great breakthrough happened, however, over the last decade in sports medicine, when some of the country’s leading athletes and ball players started swearing on PRP injections into joints and soft tissues to enhance the healing of significant sports injuries. Since then PRP has become an integral part of treatments in cardiac surgery, pediatric surgery, gynecology, urology, plastic surgery, hair restoration and ophthalmology.

PRP use for ovarian function

Red White Blood cells Artificially colored electron micrograph of blood cells, including the platelet in the middle. Public domain image from Wikimedia Commons.

A first suggestion for potential ovarian effects of PRP came, as one would expect, from animal models, when an experimental ovarian rat ischemia/reperfusion model was shown effective in treating ovarian injury (Bakkacak et al., Gynecol Obstet Invest 2016). By 2017, PRP was proposed as treatment for chronically thin endometrium (Zadehmodarres et al., JBRA Health Sci 2017). By 2018, quite a number of IVF centers in Europe, India and the U.S. had started offering intraovarian PRP injections, at times calling the procedure “ovarian rejuvenation.”

As has become the unfortunate common practice in infertility centers, these treatments gained popularity and found increasing utilization, even though, basically to this day, no literature exists that would define patient populations suitable for PRP treatments, whether intraovarian, endometrial or anywhere else. Some colleagues (who will remain unnamed), indeed, publish anecdotal experiences with small groups of patients which really have no meaning whatsoever because, often, patients were not even correctly diagnosed, claiming to treat primary ovarian insufficiency (POI), also called primary ovarian failure (POI) patients, while actually just treating women with low functional ovarian reserve, a diagnosis called premature ovarian aging (POA) or occult primary ovarian insufficiency (oPOI).

The initial claims of efficacy for PRP injections into ovaries suggested this treatment as a remedy to activate non-responsive ovaries in women with POF/POI, but a careful review of those studies revealed that so-treated patients really were not POF/POI patients but, simply, had low ovarian reserve. At time of this writing, a little over 20 publications have appeared in the literature claiming a whole variety of beneficial effects for PRP in clinical infertility treatments (see Table 1). Though some articles involving animal models are of interest and, indeed, support potential benefits, the truth is, as so many times pointed out in these pages before, that the infertility field, once again, is ahead of itself by applying treatments as clinical “routine” which are anything but routine because nobody knows who should be treated and what outcomes patients can really expect.

table 1 1024x306 List of commonly used PRP treatments for fertility, with varying degree of validity.

CHR's PRP-I study for POF/POI

CHR decided over a year ago to do things differently and announced a registered study of PRP injection, randomized to only one ovary, strictly in women with POF/POI , while the other ovary served as control (we now call this PRP-I study) [LINK]. This study quickly became extremely popular and attracted participants from all over the world, but we quickly learned that, since many interested patients were older than 40 years (the cut-off for the diagnosis POF/POI), they did not qualify for the study. Like POF/POI patients, many were, indeed, in early menopause (between ages 40-51 years), though they did not qualify for a diagnosis of POF/POI (for which women need to be under age 40), while others did not meet minimum FSH levels required for any menopause diagnosis (at least 40.0 mIU/mL) yet, still, their ovaries were absolutely resistant to stimulation.

CHR's PRP-II study for women over 40 with LFOR

CHR, therefore, decided to initiate a second registered PRP study for this older patient population, which we call the PRP-II study. As expected, participants in this study quickly outnumbered those in the PRP-I study, but still did not meet all the demand we encountered. PRP-II is a so-called cohort study without randomization.

CHR's PRP-III study for women with POA

There was a third group of patients who were very interested in administration of PRP into their ovaries, and this group included women who were neither in premature ovarian failure (POF/POI) nor in early menopause and also still produced a small number of eggs and embryos (2 or fewer embryos). Because of small egg numbers, they usually qualified for the diagnosis of POA (oPOI). With standard CHR treatments, they, however, did not produce adequate numbers of eggs and embryos to ovtain a reasonable pregnancy chance with IVF. And so, CHR recently started a third IRB-approved and registered trial for these patients, called the PRP-III study.

PRP-III is again a randomized study, but this time randomization is between PRP and another _ineffective _blood fraction of the patient. Participating women, therefore, have a 50/50 chance of getting PRP or placebo. Those who end up with placebo and did not conceive, automatically receive PRP in their next cycle. Table 2 summarizes qualifications patients must meet to join one of these three studies.

table 2 1024x416 CHR's PRP for "ovarian rejuvenation" studies participation criteria

This will be it for studies investigating the intraovarian injection of PRP. If there is to be a fourth PRP study at CHR, it will likely involve the use of intrauterine PRP in cases of chronically this endometrium and/or suspected implantation failure; but that will, still, take some time because everybody is busy now with the first three PRP studies.Interested in participating in one of these three studies? Please call +(001) 212-994 440, and tell our staff which PRP study you are interested in.

This is a part of the March 2020 CHR VOICE.

Norbert Gleicher, MD, FACOG, FACS

Norbert Gleicher, MD, FACOG, FACS

Norbert Gleicher, MD, leads CHR’s clinical and research efforts as Medical Director and Chief Scientist. A world-renowned specialist in reproductive endocrinology, Dr. Gleicher has published hundreds of peer-reviewed papers and lectured globally while keeping an active clinical career focused on ovarian aging, immunological issues and other difficult cases of infertility.

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