CHR is very pleased to announce that the center’s Institutional Review Board (IRB) approved on March 22, 2018 the proposed study, which will involve injection of the patient’s own platelet-rich plasma (PRP) into one of her two ovaries, with the other ovary serving as control.
Here is a brief summary of the study:
All women under age 40 who suffer from so-called primary ovarian insufficiency (POI), also called premature ovarian failure (POF) or premature menopause.
POI/POF diagnosis requires patients to be under age 40. Women with early menopause (above age 40) will be offered the treatment under experimental consent but outside of the IRB-approved clinical trial.
PRP is a fraction of blood, which contains different bio-active substances called lymphokines and/or cytokines, produced by white blood cells. These cell populations have in various areas of medicine, such as orthopedics, rheumatology, dermatology and others, been demonstrated to exert beneficial effects on mostly inflammatory conditions. The hope is that these substances will reconstitute the ability of remaining follicles within ovaries to respond to stimulation by fertility drugs. (Even women in menopause, still, do have follicles in their ovaries.)
There are lots of data published in other areas of medicine that suggest that PRP, indeed, can beneficially affect disease states in the body through local injections. There are, however, no such studies published in the infertility literature, suggesting improvements in ovarian response in POF/POI patients. European colleagues, however, were the first to orally report at meetings the alleged beneficial effects from intra-ovarian injections of PRP in women with POF/POI but absence of written reports is somewhat disturbing (see also this report in this month's VOICE).
Yes, quite a number of centers around the world have started using PRP in routine clinical practice and with, at times, remarkably high fees, even though not one published study in the literature has so far appeared to suggest that PRP administration in POF/POI really works. Some of these center, indeed, are in the U.S., especially in New York City and Los Angeles. This is exactly why CHR is introducing PRP within a strict protocol-driven prospective clinical trial, and why CHR does not charge for production of patients’ PRP in CHR’ s laboratory and the injection procedure.
The expectation is that it will take ca. 40 patients to determine whether the treatment works in some patients or not.
The first step is an appointment with one of CHR’s physicians in order to become a CHR patient and to determine whether you qualify for the study. You need to be under the age of 40 and have POF/POI without an obvious cause in order to qualify for the study. An obvious cause of POF/POI disqualifies from the trial. As already noted, if you do not qualify for the study, you, still, may be eligible to receive PRP outside the clinical trial under an experimental consent. If you are under age 40, and suffer from unexplained POF/POI, your only option to receive PRP will, however, be through participation in the trial.
Once you received an injection of PRP into one ovary, you will be monitored closely for development of new small follicles for at least 2-3 months. If development of new follicles is observed under ultrasound, those follicles will receive supporting ovarian stimulation with fertility drugs.
As already noted, there are no charges for preparation of PRP and for the injection procedure into the ovary. However, there are discounted charges for anesthesia services (provided by an outside physician) and for the operating room facility where the intra-ovarian injection is performed with the patient under mild I.V. sedation. For details about these costs, please inquire at CHR’s front desk at 212-994-4400. Should your ovaries respond and should you, therefore, enter into a ovarian stimulation cycle, possibly even leading to egg retrieval, normal service charges will become due for services provided by CHR physicians. PLEASE BE AWARE THAT MOST INSURANCE COMPANIES DO NOT REIMBURSE CHARGES FOR EXPERIMENTAL PROCEDURES!
The procedure is practically almost identical to an egg retrieval in that one of CHR’s anesthesiologists administers IV sedation to the patient. Once she is asleep (which happens within seconds), her vagina is cleaned, and an ultrasound probe is inserted to visualize the ovaries. The probe has a needle guide attached to it, through which a long needle is inserted, which then follows a trace-line on the ultrasound machine. This way, it is very simple to direct the needle toward the right spot in the ovary. In a retrieval, the needle aspirates fluid from the ovary (i.e., the follicles). Here, small amounts of fluid are injected under the capsule of the ovary, where remaining follicles are situated. At the end of the procedure, which should take no longer than 5-10 minutes, the needle, followed by the ultrasound probe are withdrawn, and the patient is woken up. Again, like in an egg retrieval, she will be watched in recovery for a little while before being discharged home. Because patients receive IV sedation, they must be picked up.
Should you have additional questions, please write to ykizawa@thechr.com. If you want to be considered for participation in the study, please call for an appointment with one of CHR’s physicians at 212-994-4400, and tell the patient representative that you are calling regarding the PRP study.
This is a part of the April 2018 CHR VOICE.
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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