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The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

NCT06206746 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2026-05-08

No results posted yet for this study

Summary

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome

Conditions

  • Polycystic Ovary Syndrome
  • Infertility, Female

Interventions

DEVICE

May Health System

The intervention includes the short-term use of the May Health System, which is comprised of three elements: (1) the May Health Needle-Catheter Ablation Device (NCAD) (the Device) a 16 gauge echogenic needle including a bipolar temperature-controlled RF ablation catheter which is clipped and secured onto a vaginal ultrasound probe; (2) the May Health Adapter which is clipped onto the ultrasound probe; and (3) the May Health Generator: a bipolar radiofrequency (RF) ablation platform utilizing the single use May Health NCAD for ovarian tissue ablation. Once the patient is under conscious sedation, the physician guides the May Health system transvaginally with the use of a transvaginal ultrasound. Once the May Health device is safely and securely positioned, the physician will deliver radio frequency energy inside the ovary in order to ablate the tissue.

Sponsors & Collaborators

  • May Health

    lead INDUSTRY

Principal Investigators

  • Karl Hansen, MD, PhD · Oklahoma University Health Sciences Center

  • Anuja Dokras, MD, PhD · Penn Fertility Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2026-12-31
Completion
2029-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06206746 on ClinicalTrials.gov