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

May 6, 2026 updated by: May Health

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of the study is to provide evidence for the safety and effectiveness of the May Health System in transvaginal ablation of ovarian tissue under transvaginal ultrasound guidance to restore ovulation in women with infertility due to polycystic ovary syndrome (PCOS) who have not responded to first-line ovulation induction treatment or are contraindicated for or decline such treatment.

Study Type

Interventional

Enrollment (Estimated)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Encino, California, United States, 91436
        • Recruiting
        • HRC Fertility - Encino
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Boostanfar, MD, FACOG
        • Sub-Investigator:
          • Roy Handelsman, MD
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Center for Reproductive Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heather Huddleston, MD
        • Sub-Investigator:
          • Marcelle Cedars, MD
    • Florida
      • Clearwater, Florida, United States, 33759
        • Recruiting
        • Florida Fertility Institute
        • Contact:
        • Principal Investigator:
          • Mark D Sanchez, MD
        • Sub-Investigator:
          • Yissa D Fonticiella, MD
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Anthony Imudia, MD
        • Sub-Investigator:
          • Lauri Hochberg, MS
        • Contact:
      • Winter Park, Florida, United States, 32792
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • SIU School of Medicine, Reproductive Endocrinology & Infertility Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • J. Ricardo Loret de Mola, MD
    • Iowa
      • Iowa City, Iowa, United States, 52240
        • Recruiting
        • University of Iowa Health Care
        • Contact:
        • Principal Investigator:
          • Abigail C Mancuso, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Cypress Medical Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • David A Grainger, MD, MPH
        • Sub-Investigator:
          • Jamie Peregrine, MD
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Recruiting
        • Johns Hopkins Fertility Center
        • Sub-Investigator:
          • James Segars, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pardis Hosseinzadeh, MD
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Recruiting
        • UMass Memorial Medical Center / UMass Chan Medical School
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Keefe, MD
        • Principal Investigator:
          • Sasmira Lalwani, MD
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48304
        • Withdrawn
        • IVF Michigan, P.C.
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Active, not recruiting
        • Washington University Fertility and Reproductive Medicine Center
    • New Jersey
      • Hasbrouck Heights, New Jersey, United States, 07604
        • Recruiting
        • University Reproductive Associates, PC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter G McGovern, MD
    • New York
      • Rochester, New York, United States, 14623
        • Active, not recruiting
        • University of Rochester, Strong Fertility Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Active, not recruiting
        • Reach Fertility
      • Raleigh, North Carolina, United States, 27617
        • Recruiting
        • UNC Fertility
        • Principal Investigator:
          • Anne Steiner, MD
        • Contact:
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Principal Investigator:
          • Michael Thomas, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Emily Hurley, MD
        • Sub-Investigator:
          • Katie Smith, MSN
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karl Hansen, MD, PhD
        • Sub-Investigator:
          • Heather Burks, MD
        • Sub-Investigator:
          • LaTasha Craig, MD
        • Sub-Investigator:
          • Michael Evans, DO
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17003
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health - Upstate
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chelsea Fox, MD
        • Sub-Investigator:
          • Paul Miller, MD
        • Sub-Investigator:
          • Johanna Von Hofe, MD
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • UT Health San Antonio
        • Contact:
        • Principal Investigator:
          • Randal Robinson, MD, MBA
        • Sub-Investigator:
          • Brenda Yauger, MD
      • Temple, Texas, United States, 76508
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Recruiting
        • UW Health Generations Fertility Care
        • Contact:
        • Principal Investigator:
          • Laura Cooney, MD
        • Sub-Investigator:
          • Aleksandar Stanic-Kostic, MD, PhD
        • Sub-Investigator:
          • Bala Bhagavath, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 to ≤ 40 years

  2. Infertility associated with oligo- or anovulation, AND EITHER:

    2.1 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10 mL and/or ovarian antral follicle count per ovary ≥ 20) OR

    2.2 Evidence of hyperandrogenemia: either clinical (hirsutism defined as modified Ferriman-Gallwey (mFG) level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens, testosterone ≥ 2.5 nmol/L, or FAI > 4)

  3. At least one ovary with ovarian volume ≥ 10.0 mL and < 28.0 mL
  4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to at least one ovary. (Note: In the situation where only one ovary is appropriately sized according to the preceding criterion, then this requirement applies to the qualifying ovary.)
  5. At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
  6. Has not responded to first-line ovulation induction treatment or is contraindicated for, or declines, such treatment
  7. Currently seeking immediate fertility
  8. Willing to comply with Clinical Investigation Plan-specified follow-up evaluations
  9. Ability to understand study requirements and has sufficient fluency in one of the approved written translations of the Patient Information and Informed consent form
  10. Signed informed consent

Exclusion Criteria:

  1. Currently pregnant
  2. BMI > 40
  3. Marked hyperandrogenism (total serum testosterone ≥ 4.5 nmol/L or 130ng/dL)
  4. Poor glycemic level control defined as glycohemoglobin (HbA1c) level > 6.5%
  5. Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use of anticoagulation medication, etc.
  6. Active genital or urinary tract infection at the time of the procedure
  7. Patient with known or suspected periovarian adhesions
  8. Previous ovarian surgery (e.g. ovarian drilling, ovarian cysts surgery, or endometriosis surgery on the ovary)
  9. Transvaginal ultrasound transducer cannot be brought into proximity of at least one ovary
  10. Presence of a pathologic cyst (i.e. endometrioma, dermoid, etc.) of any size, or a follicle, or functional cyst >15 mm on transvaginal ultrasound in ovary to be treated
  11. Received > 2 cycles of treatment with gonadotropins for ovarian stimulation without a resulting pregnancy (excludes human chorionic gonadotropin (hCG) trigger injection)
  12. Contraindicated to or known previous reaction to anesthesia or sedation regimen
  13. Patient not willing to stop all concomitant first-line ovulation induction treatment (clomiphene citrate, letrozole, as well as metformin unless metformin is required for glycemic control) until the 3-month endpoint is reached
  14. Male partner's total motile sperm count (TMSC) < 10 million or not available (unless participant is planning donor sperm IUI)
  15. Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
  16. Known or suspected gynecological malignancy
  17. General health condition or systemic disease that may contribute to anovulation, infertility, or represent in the opinion of the investigator, a potential increased risk associated with the May Health system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device arm
May Health procedure performed with the use of the May Health system intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to Polycystic Ovary Syndrome.
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.
No Intervention: Control arm
No fertility medication. Crossover participants who choose to crossover after the 3 month follow up visit will restart follow up as per the Device arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event collection
Time Frame: Day 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
Day 0 through 36 month visit
Ovulation occurrence
Time Frame: 3 month follow-up
Occurrence of at least one (1) ovulation
3 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hormone serum concentrations
Time Frame: Baseline through 36 month visit
Anti-Müllerian hormone (AMH) serum concentration (ng/mL); Androstenedione serum concentration (ng/dL); Sex Hormone Binding Globulin (SHBG) (nmol/L); Free Androgen Index (FAI)
Baseline through 36 month visit
Cumulative ovulation rate at 6 months without 1st-line medication
Time Frame: Device arm and Crossover at 6 month visit
Cumulative ovulation rate at 6 months, without 1st line medication restarted ≥ 3 months post-procedure
Device arm and Crossover at 6 month visit
Cumulative ovulation rate at 6 months with 1st-line
Time Frame: Device arm and Crossover at 6 month visit
Cumulative ovulation rate at 6 months, with 1st line medication restarted ≥ 3 months post-procedure
Device arm and Crossover at 6 month visit
Time to ovulation
Time Frame: Baseline for the control group is day of randomization to the date of first ovulation. Baseline for the treatment group is day of procedure to the date of first ovulation
Between baseline and 3-month follow-up with weekly assessment
Baseline for the control group is day of randomization to the date of first ovulation. Baseline for the treatment group is day of procedure to the date of first ovulation
Documented pregnancy
Time Frame: Control Arm, Device Arm, and Crossover group: from baseline to 30 Day, 3 Month; Device Arm and Crossover group only: 6 Month, 12 Month, 24 Month, 36 Month
Documented pregnancy at any point during the study (participant reported or medical record)
Control Arm, Device Arm, and Crossover group: from baseline to 30 Day, 3 Month; Device Arm and Crossover group only: 6 Month, 12 Month, 24 Month, 36 Month
Pain level after procedure
Time Frame: Device arm and Crossover - Baseline through 7 day visit
Measured by Visual Analog Scale (VAS) [ranked from 0 (no pain) to 10 (worst pain)], immediately after procedure completion, prior to discharge, 1-, and 7-day follow-up as well as baseline pain level reported by the participant during menstruation as reference
Device arm and Crossover - Baseline through 7 day visit
Performance of activities of daily living
Time Frame: Device arm and Crossover: baseline, 24 hours post procedure, D7
Received score from activities of daily living (ADL)
Device arm and Crossover: baseline, 24 hours post procedure, D7
Procedure times
Time Frame: Device arm and Crossover at Day 0
Includes pre-treatment, treatment, and post-treatment
Device arm and Crossover at Day 0
Time to discharge
Time Frame: Device arm and Crossover at Day 0
Defined as time from end-of-procedure until participant meets all conditions to be discharged from Post Anesthesia Care Unit (PACU)
Device arm and Crossover at Day 0
Modified Post Anaesthetic Discharge Scoring System (PADSS)
Time Frame: Device arm and Crossover at 1 hour, 2 hour post procedure
The Modified Post Anesthetic Discharge Scoring System (PADSS) score is completed after the procedure. The score evaluates whether the participant is safe to go home after anesthesia. It scores 0-2 points in each category (vital signs, activity, nausea/vomiting, pain, bleeding, intake/output), for a maximum score of 10. Discharge can occur with a score of 9 or more and a vital signs score of 2.
Device arm and Crossover at 1 hour, 2 hour post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

May Health

Investigators

  • Principal Investigator: Karl Hansen, MD, PhD, Oklahoma University Health Sciences Center
  • Principal Investigator: Anuja Dokras, MD, PhD, Penn Fertility Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data after deidentification (text, tables, figures and appendices) in annual clinical study report

IPD Sharing Time Frame

Annually, beginning 3 months following FDA submission of annual report, ending 6 months after final report.

IPD Sharing Access Criteria

Investigators participating in the study who have been approved by an institutional review board.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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