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

NCT03760926 | Completed DMC

• 1 other identifier: ULTRA
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 6

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Anovulatory infertility

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Occurrence of ovulation following the procedure

  Up to 3 months after procedure

Other Outcomes (6)

• 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

• Usability of the May Health Kit

  During procedure

• 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

Study Arms (1)

May Health Procedure

EXPERIMENTAL

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

Interventions

May Health Kit DEVICE

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.

May Health Procedure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: ≥ 18 to ≤ 40 years
• Diagnostic of PCOS confirmed by at least 2 of 3 Rotterdam criteria, defined as:
• 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)
• Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
• 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
• At least one patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
• Willing to comply with protocol-specified follow-up evaluation
• Signed informed consent
• Normal sperm parameters based on WHO 2000 criteria (concentration⩾ 15 million/mL, motility A+B ⩾ 32%, normal forms ⩾ 4%).
• Ability to have regular intercourse during the study
• 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:
• Pregnant, parturient or breastfeeding women
• Marked obesity, BMI \> 35
• Marked hyperandrogenism (FAI \> 15)

Sponsors & Collaborators

• May Health: lead

Study Sites (6)

CHU Saint-Pierre

Brussels, 1000, Belgium

Location

CU Saint-Luc

Brussels, 1200, Belgium

Location

Bicetre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

Location

Liverpool Women Hospital

Liverpool, L8 7SS, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Saad Amer, MD, PhD

  Derby Royal Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 3, 2018
• Study Start: February 14, 2019
• Primary Completion: September 2, 2023
• Study Completion: August 15, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); GB (3); BE (2)