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Transvaginal ablation of ovarian tissue to restore ovulation in women with PCOS-related infertility

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

Not applicable Interventional May Health · NCT06206746

This study is testing a new procedure to see if removing some ovarian tissue can help women with PCOS-related infertility start ovulating again when other treatments haven't worked.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment195 (estimated)
Ages18 Years to 40 Years
SexFemale
SponsorMay Health Industry-sponsored
Locations24 sites (Encino, California and 23 other locations)
Trial IDNCT06206746 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the May Health System for transvaginal ablation of ovarian tissue under ultrasound guidance in women suffering from infertility due to polycystic ovary syndrome (PCOS). It targets women aged 18 to 40 who have not responded to first-line ovulation induction treatments or are unable to undergo such treatments. The study is multicenter and randomized, aiming to provide robust evidence for this innovative approach to restore ovulation. Participants will be monitored for outcomes related to ovulation restoration and fertility.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 40 with infertility linked to oligo- or anovulation and evidence of PCOS.

Not a fit: Patients who do not have PCOS or those who have not experienced infertility related to ovulation issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for women with PCOS-related infertility who have limited alternatives.

How similar studies have performed: While similar approaches have been explored, this specific method of transvaginal ablation under ultrasound guidance is novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Encino, California and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Polycystic Ovary SyndromeInfertility, FemalePCOSInfertility related to PCOSOvulation restoration
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.