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

Not Applicable

Active, not recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Device: May Health Kit

• Registration Number: NCT03760926
• Lead Sponsor: May Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-12-03
• Study Start: 2019-02-14
• Primary Completion: 2023-09-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
May Health Procedure	May Health Kit	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Occurrence of ovulation following the procedure	Up to 3 months after procedure

Trial Locations

Locations (6)

CHU Saint-Pierre; 🇧🇪 Bruxelles, Belgium

Bicetre Hospital; 🇫🇷 Le Kremlin-Bicêtre, France

Royal Derby Hospital; 🇬🇧 Derby, United Kingdom

Liverpool Women Hospital; 🇬🇧 Liverpool, United Kingdom

Royal Hallamshire Hospital; 🇬🇧 Sheffield, United Kingdom

CU Saint-Luc; 🇧🇪 Bruxelles, Belgium