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

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: Active, not recruiting
• Conditions: Polycystic Ovary Syndrome; Infertility, Female
• Intervention / Treatment: Device: May Health System

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

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • HRC Fertility - Encino
    • San Francisco, California, United States, 94158
      • UCSF Center for Reproductive Health
  • Florida
    • Clearwater, Florida, United States, 33759
      • Florida Fertility Institute
    • Tampa, Florida, United States, 33606
      • University of South Florida
    • Winter Park, Florida, United States, 32792
      • The IVF Center
  • Illinois
    • Springfield, Illinois, United States, 62702
      • SIU School of Medicine, Reproductive Endocrinology & Infertility Center
  • Iowa
    • Iowa City, Iowa, United States, 52240
      • University of Iowa Health Care
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center
  • Maryland
    • Lutherville, Maryland, United States, 21093
      • Johns Hopkins Fertility Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center / UMass Chan Medical School
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University Fertility and Reproductive Medicine Center
  • New Jersey
    • Hasbrouck Heights, New Jersey, United States, 07604
      • University Reproductive Associates, PC
  • New York
    • Rochester, New York, United States, 14623
      • University of Rochester, Strong Fertility Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Reach Fertility
    • Raleigh, North Carolina, United States, 27617
      • UNC Fertility
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17003
      • Penn State College of Medicine
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Fertility Care
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health - Upstate
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Medical Center
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • UW Health Generations Fertility Care

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Occurrence of at least one (1) ovulation	3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hormone serum concentrations	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	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	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	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	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	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	Received score from activities of daily living (ADL)	Device arm and Crossover: baseline, 24 hours post procedure, D7
Procedure times	Includes pre-treatment, treatment, and post-treatment	Device arm and Crossover at Day 0
Time to discharge	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)	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

• 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

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): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: PCOS; Infertility related to PCOS; Ovulation restoration
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Infertility; Polycystic Ovary Syndrome; Infertility, Female
• 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