Physicians at the University of Oklahoma Health Sciences in Oklahoma City are leading a national clinical trial over an investigational device to study if it can help women with polycystic ovary syndrome (PCOS) struggling with infertility.
PCOS is a hormonal disorder that affects about 10% of women of reproductive age. Dr. Karl Hansen, the chair of the Department of Obstetrics and Gynecology at the OU College of Medicine, said it can cause irregular periods, excessive hair growth, acne and oily skin.
PCOS can also disrupt ovulation. It’s a leading cause of infertility.
Hansen said some PCOS symptoms can be managed with oral contraceptive pills, but if women want to get pregnant, they have had to pursue other methods. Some respond to oral medications designed to stimulate ovulation, but others don’t.
Hansen said alternative treatments include injections of gonadotropins, which are effective but require constant monitoring because they carry an increased risk of causing women to have more than one baby. Laparoscopic ovarian drilling is also available, where a needle-like device is inserted through small abdominal incisions to deliver laser or radiofrequency energy to an ovary. He said it’s become less common.
In vitro fertilization (IVF) is also an option. Hansen said many women who don’t ovulate in response to oral medications are encouraged to do it. But he said it’s expensive and requires certain centers with specific expertise.
“There's this gap in care where we're going straight from you don't respond to oral medicines to doing IVF,” Hansen said. “And while that may make sense in certain patient populations where there are other factors in play, for the patient who has no other infertility problems – [they’re] just not ovulating – it would be nice to have another alternative.”
Enter May Health: a clinical-stage medical device company “committed to developing treatment options for women living with PCOS.” Hansen got connected to the group when it asked him to be a part of their data and safety monitoring board for a trial they were doing related to the device in Europe. Hansen became the first physician in the U.S. to use the device.
“They recognized that our site, because we have a lot of experience doing clinical trials, might be a good place to do a trial in the U.S. And so we participated in a pilot trial a couple of years ago where we did this procedure on five patients that had failed to ovulate in response to oral medicines, and we had good success rates here in terms of ovulation, as did the European study,” Hansen said.
Now, the larger-scale REBALANCE trial will study the safety and effectiveness of this device, which seeks to prompt ovulation in women with PCOS-related infertility through a less invasive ablation procedure.
The device connects to a probe commonly used in transvaginal ultrasounds, which evaluates the ovary before delivering a certain amount of electrothermal energy to it.
“Not only does this allow a less invasive procedure in our office, but it also allows us to deliver a pre-calculated amount of energy to the ovary based on the volume of it, which is very different than what we did historically,” Hansen said.
The trial is being co-led by OU Health Sciences and the University of Pennsylvania. It will enroll approximately 195 patients with PCOS-related infertility at multiple sites across the country. Hansen said a third of the women will be randomized to no treatment for the first three months, while the other women will have the procedure right away.
He said they’ll monitor them regularly to look for signs of ovulation. After three months, Hansen said the patients in the control arm could cross over and get the procedure.
Secondary outcomes they’ll measure include pregnancy rates achieved post-procedure and how long its effects endure.
“Me and my partners all firmly believe that we should be part of advancing the standard of care. We're not just here to practice the standard of care and to teach it to our learners here,” Hansen said. “Being a part of investigation both with this study, as well as many of the other ones we participate in, is incredibly important in our field and for our patients.”
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