An interventional study of May Health System in Polycystic Ovary Syndrome and Infertility, Female, sponsored by May Health. Terminated at 19 sites in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by May Health · Not applicable, Interventional, and Treatment
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
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 93 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →May Health is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Exclusion Criteria:
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
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.
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.
Ovulation occurrence
Occurrence of at least one (1) ovulation
Time frame: 3 month follow-up
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
Time frame: Day 0 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
Time frame: 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
Time frame: Device arm and Crossover at 6 month visit
Time to ovulation
Between baseline and 3-month follow-up with weekly assessment
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
Documented pregnancy
Documented pregnancy at any point during the study (participant reported or medical record)
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
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)
Time frame: Baseline through 36 month visit
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
Time frame: Device arm and Crossover - Baseline through 7 day visit
Performance of activities of daily living
Received score from activities of daily living (ADL)
Time frame: Device arm and Crossover: baseline, 24 hours post procedure, D7
Procedure times
Includes pre-treatment, treatment, and post-treatment
Time frame: 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)
Time frame: 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.
Time frame: Device arm and Crossover at 1 hour, 2 hour post procedure
Plan to share: Yes — Individual participant data after deidentification (text, tables, figures and appendices) in annual clinical study report
Supporting information: Study protocol, Icf, Csr
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
May Health