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Polycystic Ovary SyndromeNCT06206746

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

A study testing May Health System in people with Polycystic Ovary Syndrome and Infertility, Female, run by May Health at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 40 years, women only
What is being tested?
May Health System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
19 sitesUnited States
Study dates
25 Mar 2024to 3 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age ≥ 18 to ≤ 40 years
  • 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)
  • At least one ovary with ovarian volume ≥ 10.0 mL and < 28.0 mL
  • 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.)
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  • At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
  • Has not responded to first-line ovulation induction treatment or is contraindicated for, or declines, such treatment
  • Currently seeking immediate fertility
  • Willing to comply with Clinical Investigation Plan-specified follow-up evaluations
  • Ability to understand study requirements and has sufficient fluency in one of the approved written translations of the Patient Information and Informed consent form
  • Signed informed consent

Who cannot join

  • Currently pregnant
  • BMI > 40
  • Marked hyperandrogenism (total serum testosterone ≥ 4.5 nmol/L or 130ng/dL)
  • Poor glycemic level control defined as glycohemoglobin (HbA1c) level > 6.5%
  • Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use of anticoagulation medication, etc.
  • Active genital or urinary tract infection at the time of the procedure
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  • Patient with known or suspected periovarian adhesions
  • Previous ovarian surgery (e.g. ovarian drilling, ovarian cysts surgery, or endometriosis surgery on the ovary)
  • Transvaginal ultrasound transducer cannot be brought into proximity of at least one ovary
  • 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
  • Received > 2 cycles of treatment with gonadotropins for ovarian stimulation without a resulting pregnancy (excludes human chorionic gonadotropin (hCG) trigger injection)
  • Contraindicated to or known previous reaction to anesthesia or sedation regimen
  • 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
  • Male partner's total motile sperm count (TMSC) < 10 million or not available (unless participant is planning donor sperm IUI)
  • Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
  • Known or suspected gynecological malignancy
  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Reach Fertility

    Charlotte, North Carolina, 28207

  • HRC Fertility - Encino

    Encino, California, 91436

  • Prisma Health - Upstate

    Greenville, South Carolina, 29605

  • Penn State College of Medicine

    Hershey, Pennsylvania, 17003

  • University of Iowa Health Care

    Iowa City, Iowa, 52240

  • Johns Hopkins Fertility Center

    Lutherville, Maryland, 21093

  • UW Health Generations Fertility Care

    Middleton, Wisconsin, 53562

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Penn Fertility Care

    Philadelphia, Pennsylvania, 19104

  • UNC Fertility

    Raleigh, North Carolina, 27617

  • University of Rochester, Strong Fertility Center

    Rochester, New York, 14623

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • UCSF Center for Reproductive Health

    San Francisco, California, 94158

  • SIU School of Medicine, Reproductive Endocrinology & Infertility Center

    Springfield, Illinois, 62702

  • Washington University Fertility and Reproductive Medicine Center

    St Louis, Missouri, 63110

  • University of South Florida

    Tampa, Florida, 33606

  • Baylor Scott & White Medical Center

    Temple, Texas, 76508

  • Cypress Medical Research Center

    Wichita, Kansas, 67226

  • The IVF Center

    Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: 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

Read the 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.

Being tested
May Health System
Keywords
PCOS, Infertility related to PCOS, Ovulation restoration
Medical subject headings
Polycystic Ovary Syndrome, Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • May Health SystemDevice

    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.

Study groups in NCT06206746
Study groupRoleWhat they receive
Device armExperimentalMay 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.
Receives: Device: May Health System
Control armNo interventionNo 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Ovulation occurrence

    Occurrence of at least one (1) ovulation

    Measured: 3 month follow-up

  2. 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

    Measured: Day 0 through 36 month visit

Secondary outcomes (10)

  1. 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

    Measured: Device arm and Crossover at 6 month visit

  2. Cumulative ovulation rate at 6 months with 1st-line

    Cumulative ovulation rate at 6 months, with 1st line medication restarted ≥ 3 months post-procedure

    Measured: Device arm and Crossover at 6 month visit

  3. Time to ovulation

    Between baseline and 3-month follow-up with weekly assessment

    Measured: 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

  4. Documented pregnancy

    Documented pregnancy at any point during the study (participant reported or medical record)

    Measured: 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

  5. 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)

    Measured: Baseline through 36 month visit

  6. 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

    Measured: Device arm and Crossover - Baseline through 7 day visit

  7. Performance of activities of daily living

    Received score from activities of daily living (ADL)

    Measured: Device arm and Crossover: baseline, 24 hours post procedure, D7

  8. Procedure times

    Includes pre-treatment, treatment, and post-treatment

    Measured: Device arm and Crossover at Day 0

  9. Time to discharge

    Defined as time from end-of-procedure until participant meets all conditions to be discharged from Post Anesthesia Care Unit (PACU)

    Measured: Device arm and Crossover at Day 0

  10. 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.

    Measured: Device arm and Crossover at 1 hour, 2 hour post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2024
  2. Study start25 Mar 2024
  3. Primary completion12 Aug 2026
  4. Study completion3 Sep 2026

Why it stopped: Business decision by sponsor to terminate the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Control arm has the option to crossover to receive the May Health procedure after completion of the 3 month primary endpoint visit.
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06206746
Sponsor's protocol ID
CR003
Status last verified
Sep 2026
First submitted
12 Dec 2023
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Individual participant data after deidentification (text, tables, figures and appendices) in annual clinical study report

Questions about this trial

What is this clinical trial studying?

A study testing May Health System in people with Polycystic Ovary Syndrome and Infertility, Female, run by May Health at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Business decision by sponsor to terminate the study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ovulation occurrence (time frame: 3 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06206746.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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