Novel PCOS treatment shows ‘great promise’ in clinical trials

A French medical device company has unveiled promising clinical trial results for a “novel” polycystic ovary syndrome treatment.

May Health has announced preliminary data supporting the safety and effectiveness of its Ovarian Rebalancing treatment for inducing ovulation in women with PCOS-related infertility at the this year’s ESHRE meeting in Copenhagen.

The company has received the US FDA’s approval of its REBALANCE study, designed to evaluate the safety and effectiveness of Ovarian Rebalancing in women with PCOS-related infertility.

PCOS is a common condition affecting around one in 10 women in the UK.

Women with PCOS may experience symptoms such as irregular periods, high levels of “male” hormones, known as androgens, and a cystic appearance of the ovaries on ultrasound caused by the ovarian follicles becoming arrested in their development towards releasing an egg.

The “novel” one-time treatment aims to lower androgen production, which can often restore ovulation, through targeted ovarian ablation.

Saad Amer, professor of gynaecology and reproductive medicine at the University of Nottingham and lead investigator, said: “Infertility is an emotional journey, and current options available to achieve pregnancy are often expensive, invasive, and do not work for all women, adding burden to the experience.

“The new data shows great promise for Ovarian Rebalancing as a safe and effective office-based treatment to induce ovulation in women who have not achieved results from first-line medications.”

To date, a pregnancy rate of 35 per cent was observed for the 23 participants who received Ovarian Rebalancing and completed six months of follow-up, including some patients who re-started first-line ovulation induction medication between three and six months, the trials found.

Results showed 44 per cent of women ovulated spontaneously during the first three months after undergoing Ovarian Rebalancing.

The trials also showed the ovulation rate increased to 65 per cent between three and six months, with the re-introduction of first-line medication at three months post procedure.

In 100 per cent of patients, ablation was achieved successfully in at least one ovary, the studies found, with 84 per cent of patients receiving the targeted ablation in both ovaries.

No serious adverse events related to the device were reported. The most common adverse events related to the procedure were mild and included vaginal bleeding, pain, and headache.

Anne Morrissey, CEO of May Health, said: “In addition to being the leading cause of infertility, PCOS causes other major health challenges and women lack options to address the needs of this disorder.

“Our team recognises the need for innovative treatments for PCOS, and the data from our trials show that Ovarian Rebalancing has the potential to shift the treatment landscape for this patient population.

“We are eager to continue our research with the US pivotal trial and explore additional endpoints in future studies to assess the potential of Ovarian Rebalancing as a treatment for other symptoms of PCOS.”

Antoine Papiernik, chairman and managing partner of Sofinnova Partners, said: “The inception of May Health within our medtech accelerator was fuelled by a firm belief in the transformative potential of its technology.

“The success of these feasibility studies and the FDA’s approval of the pivotal REBALANCE study only serve to reinforce our initial conviction. We look forward to seeing this technology revolutionise the field of infertility treatment.”