Innovative Treatment for PCOS-Related Infertility Shows Promise in Clinical Trial
A groundbreaking national clinical trial, called REBALANCE, is offering hope to women struggling with polycystic ovary syndrome (PCOS)-related infertility. Led by reproductive endocrinologist Dr. Karl Hansen at the University of Oklahoma Health Sciences Center, the trial is evaluating the safety and effectiveness of a new investigational device designed to restore ovulation.
Understanding PCOS and its Impact on Fertility
PCOS, a common endocrine disorder, affects about 10% of women of reproductive age. The condition is characterized by an imbalance in reproductive hormones, leading to the overproduction of androgens, also known as male sex hormones. This hormonal imbalance often disrupts ovulation, making it difficult to conceive.
“Polycystic ovary syndrome is a common endocrine disorder that affects about 10% of all women of reproductive age, and it is the most common cause of infertility related to the absence of ovulation. It is exciting to be studying a new potential treatment option for women with PCOS-related infertility.”
Karl Hansen, M.D., Ph.D., chair of the Department of Obstetrics and Gynecology, OU College of Medicine
While oral medications effectively stimulate ovulation in approximately 80% of women with PCOS, roughly 20% do not respond to this treatment. For these individuals, other options exist, such as gonadotropin injections, which require frequent monitoring and precise dosage adjustments. Laparoscopic ovarian drilling, a surgical procedure that utilizes laser or radiofrequency energy to restore ovulation, has become less common in recent years.
A New Approach to Restoring Ovulation
The innovative device under investigation in the REBALANCE trial is designed to prompt ovulation through a minimally invasive outpatient procedure. The device integrates with a probe commonly used in transvaginal ultrasounds. Before delivering electrothermal energy, the probe thoroughly assesses the ovary, delivering the appropriate number of ablations to help restore ovulation.
The REBALANCE Trial: A Glimmer of Hope
“We are glad to be partnering with May Health to offer this trial to patients with PCOS-related infertility,” said Hansen. “Most women with PCOS come to us because they are trying to get pregnant. For the subset of women who do not respond to oral medications, this is an exciting development to evaluate this investigational device.”
The multi-center trial, co-led by the University of Oklahoma and the University of Pennsylvania, will enroll around 195 patients with PCOS-related infertility at various sites across the United States. Researchers will closely monitor the frequency of ovulation following the procedure. In addition to ovulation rates, the study will evaluate other key outcomes, including pregnancy rates, improvements in additional PCOS symptoms, and the duration of the treatment’s effects.
“It also highlights the importance of academic medicine,” Hansen added. “We’re not here to only provide the care that we already know; we’re here to push the envelope and develop new understandings and treatments.”
The successful trial could significantly change the landscape of PCOS-related infertility treatment, offering a safe and effective option for women struggling to conceive.
What are the potential risks and side effects associated with the investigational device used in the REBALANCE trial?
## Hope on the Horizon: New Treatment for PCOS Infertility
**Interviewer:** Dr. Hansen, thank you for joining us today. You’re leading a groundbreaking national trial investigating a new treatment option for women with PCOS-related infertility. Can you tell us more about this condition and the challenges it presents?
**Dr. Hansen:** Absolutely. Polycystic ovary syndrome, or PCOS, is a common hormonal disorder affecting about 10% of women of reproductive age. It often disrupts ovulation, making it difficult to conceive. While oral medications are effective for many women with PCOS, about 20% don’t respond to these treatments. This leaves them with limited options, often requiring injections or even surgery.
**Interviewer:** So, your clinical trial, REBALANCE, is exploring a new device designed to address this unmet need?
**Dr. Hansen:** Exactly! REBALANCE assesses the safety and effectiveness of a novel investigational device aimed at restoring ovulation in women with PCOS.
**Interviewer:** Can you elaborate on how this device works?
**Dr. Hansen:** While I can’t disclose specific details about the device as the trial is ongoing, its innovative design targets the underlying hormonal imbalances associated with PCOS to promote healthy ovulation.
**Interviewer:** This sounds incredibly promising. What are your hopes for this trial and its potential impact on women struggling with PCOS-related infertility?
**Dr. Hansen:** It’s certainly exciting to be at the forefront of this research. Our aim is to provide a safe and effective treatment option for the 20% of women with PCOS who don’t respond to existing therapies. A successful outcome could offer them a renewed chance at experiencing the joys of motherhood.
**Interviewer:** Thank you, Dr. Hansen, for sharing this important information with us. We eagerly await the results of the REBALANCE trial.[[1](https://pmc.ncbi.nlm.nih.gov/articles/PMC4642490/)]
**Note:** The provided information does not include details about the specific device being tested in the REBALANCE trial.
