Clinical Evidence

The REBALANCE Study Is Here

We provide scientific publications and presentations regarding the Anavi™ System here for your convenience. May Health’s Anavi System is CE Mark certified under EU MDR and is currently enrolling the REBALANCE study in the United States, a pivotal Investigational Device Exemption (IDE) trial designed to support submission to the U.S. Food and Drug Administration (FDA) for marketing authorization. The below scientific information represents data from preliminary evaluations of the safety and effectiveness of the device and procedure and should not be interpreted as claims of safety or effectiveness about the device or procedure.

Hansen, K., et. al.

The ULTRA trials: transvaginal ULTRAsound-guided ovarian ablation using the May Health System in women with Polycystic Ovary Syndrome (PCOS)-related infertility: up to twelve months follow up

Fertility & Sterility 2023.08.848

These preliminary data suggest that the novel May Health TVUS-guided ovarian ablation System can be an effective method for restoring ovulation in women with PCOS desiring pregnancy who are resistant to first line oral medications such as clomiphene and letrozole. Larger multicenter studies are necessary to confirm these findings and to determine the duration of effects as well as the metabolic impact.

Amer, S., et. al.

The ULTRA trial: transvaginal ULTRAsound-guided ovarian ablation using the novel May Health device in women with PCOS-related infertility: first–in-human feasibility clinical trial

Human Reproduction, Volume 38, Issue Supplement_1, June 2023, dead093.010

These preliminary data suggest that the novel May Health device offers a promising office-based second line ovulation inducing procedure for CC/Letrozole-resistant anovulatory PCOS women.