A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility

ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS)

The objective of this study is to provide preliminary evidence for the safety and effectiveness of the May Health Kit in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Device: May Health Kit

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • CHU Saint-Pierre
  • Brussels, Belgium, 1200
    • CU Saint-Luc
• France
  • Le Kremlin-Bicêtre, France, 94270
    • Bicetre Hospital
• United Kingdom
  • Derby, United Kingdom, DE22 3NE
    • Royal Derby Hospital
  • Liverpool, United Kingdom, L8 7SS
    • Liverpool Women Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Royal Hallamshire Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Candidates for this study must meet ALL of the following criteria:

Inclusion criteria for female participants:

1. Age: ≥ 18 to ≤ 40 years

2. Diagnostic of PCOS confirmed by at least 2 of 3 Rotterdam criteria, defined as:

   2.1 Infertility associated with chronic anovulation or oligomenorrhea, defined as spontaneous intermenstrual periods of ≥35 days or a total of ≤9 menses per year 2.2 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or follicle number per ovary of ≥ 20) 2.3 Evidence of hyperandrogenaemia: either clinical (hirsutism or acne) or biochemical (raised serum concentration of androgens (testosterone ≥ 2.5nmol/l, or FAI > 4)

3. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
4. Resistance to first-line pharmacological treatment, defined as at least 2 consecutive non-ovulatory cycles, including at least 1 cycle at the highest dose deemed clinically relevant for the patient
5. At least one patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
6. Willing to comply with protocol-specified follow-up evaluation

7. Signed informed consent

   Couple inclusion criteria:

8. Normal sperm parameters based on WHO 2000 criteria (concentration⩾ 15 million/mL, motility A+B ⩾ 32%, normal forms ⩾ 4%).
9. Ability to have regular intercourse during the study
10. No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed

Candidates will be excluded from the study if ANY of the following conditions apply:

1. Pregnant, parturient or breastfeeding women
2. Marked obesity, BMI > 35
3. Marked hyperandrogenism (FAI > 15)
4. Previous ovarian surgery: LOD, endometriosis surgery, ovarian cysts surgery, patients with known or suspected periovarian adhesions.
5. Subject with pacemaker, defibrillator or other active implant
6. Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
7. Lack of capacity to give informed consent (individuals deprived of their liberty subject to a legal protection measure or who are unable to express their consent, individuals under guardianship or curatorship)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: May Health Procedure; May Health Procedure performed with use of the May Health Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

Device: May Health Kit; The intervention consists in the realisation of the May Health Procedure using the May Health Kit, which comprises two elements: a disposable device (May Health Device) and a radiofrequency (RF) energy generator (May Health System). The May Health Device is a short-term invasive device delivered and positioned through the vagina to deliver RF energy inside the ovary in order to ablate ovarian tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications	Up to 30 days
Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization.	During procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of ovulation following the procedure	Up to 3 months after procedure

Other Outcome Measures

Outcome Measure	Time Frame
Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered during procedure	At procedure, 7 days, 30 days
Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered post-procedure	At 30 days
Occurrence of ovulation following the procedure	Up to 6 months after procedure
Pregnancy	At 3, 6, 9 12 and 24 months
Usability of the May Health Kit	During procedure
May Health Procedure time	During procedure

Collaborators and Investigators

• Sponsor: May Health
• Investigators: Study Director: Saad Amer, MD, PhD, Derby Royal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2019
• Primary Completion (Actual): September 2, 2023
• Study Completion (Actual): August 15, 2025

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Anovulatory infertility
• 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; Polycystic Ovary Syndrome
• Other Study ID Numbers: ULTRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No