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The REBALANCE Study: May Health System for Infertility due to PCOS

The REBALANCE Study is looking at a new treatment called the May Health System for women aged 18 to 40 who have infertility because of Polycystic Ovary Syndrome (PCOS). This system uses a special needle-catheter device to treat ovarian tissue. The goal is to see if this treatment can help restore ovulation (when an egg is released) and if it is safe. You might be able to join if you have PCOS-related infertility and haven't responded to other treatments, or can't use them. The study will measure if ovulation occurs after 3 months and will track any side effects for up to 36 months. The current recruitment status is unclear.

Study design
This is a prospective, multicenter, randomized study planning to enroll 195 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for ovulation occurrence at 3 months and for adverse events from the start of the study through a 36-month visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06206746

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

Active, Not Recruiting
NAAges 18–40InterventionalTreatment
May Health
~195 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:May Health System

At a glance

Recruiting sites
0 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ovulation occurrence
Measured over 3 month follow-up
+1 more outcome measured

Conditions

Polycystic Ovary Syndrome
Infertility, Female

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Where it's being run

19 sites across 14 states
California2
Florida2
North Carolina2
Pennsylvania2
Texas2
Illinois1
Iowa1
Kansas1

Study leadership

  • Karl Hansen, MD, PhD · PRINCIPAL_INVESTIGATOR · Oklahoma University Health Sciences Center
  • Anuja Dokras, MD, PhD · PRINCIPAL_INVESTIGATOR · Penn Fertility Care

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Ovulation occurrence3 month follow-up

    Occurrence of at least one (1) ovulation

  • Adverse event collectionDay 0 through 36 month visit

    Adverse events will be collected between and at each study visit after randomization and throughout the duration of the study and analyzed for seriousness, severity, relatedness to the device and/or the procedure, and whether anticipated