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Zapping ovaries: could a quick procedure replace daily pills for PCOS infertility?

NCT ID NCT06206746

Disease control Sponsor: May Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 6 times

Summary

This study tests a device that uses heat to ablate (destroy) a small part of the ovary in women with polycystic ovary syndrome (PCOS) who have trouble getting pregnant. The goal is to restore ovulation without needing daily medication. About 195 women will be randomly assigned to receive the procedure or a sham, and researchers will track ovulation rates and side effects over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
May Health System (radiofrequency ablation device)
What this could lead to
If successful, this could offer a one-time, drug-free option to help women with PCOS ovulate and become pregnant naturally.
What could go wrong
This is an early pivotal trial with 195 participants, so results may not apply to all. The procedure carries risks like infection or ovarian damage, and it may not restore ovulation in everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

93 people

The number who actually took part.

Started

Mar 2024

Finished

Sep 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

female infertility polycystic ovary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infertility, female Polycystic ovary syndrome

Contacts and locations

Locations

  • Baylor Scott & White Medical Center

    Temple, Texas, 76508, United States

  • Cypress Medical Research Center

    Wichita, Kansas, 67226, United States

  • HRC Fertility - Encino

    Encino, California, 91436, United States

  • Johns Hopkins Fertility Center

    Lutherville, Maryland, 21093, United States

  • Penn Fertility Care

    Philadelphia, Pennsylvania, 19104, United States

  • Penn State College of Medicine

    Hershey, Pennsylvania, 17003, United States

  • Prisma Health - Upstate

    Greenville, South Carolina, 29605, United States

  • Reach Fertility

    Charlotte, North Carolina, 28207, United States

  • SIU School of Medicine, Reproductive Endocrinology & Infertility Center

    Springfield, Illinois, 62702, United States

  • The IVF Center

    Winter Park, Florida, 32792, United States

  • UCSF Center for Reproductive Health

    San Francisco, California, 94158, United States

  • UNC Fertility

    Raleigh, North Carolina, 27617, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • UW Health Generations Fertility Care

    Middleton, Wisconsin, 53562, United States

  • University of Iowa Health Care

    Iowa City, Iowa, 52240, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester, Strong Fertility Center

    Rochester, New York, 14623, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • Washington University Fertility and Reproductive Medicine Center

    St Louis, Missouri, 63110, United States

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