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

Primary Purpose

Polycystic Ovary Syndrome

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

May Health Kit

About this trial

This is an interventional device feasibility trial for Polycystic Ovary Syndrome focused on measuring Anovulatory infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Inclusion criteria for female participants:

Age: ≥ 18 to ≤ 40 years
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)
Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
Failure of first-line pharmacological treatment defined as failure to ovulate on the highest dose of first line pharmacological treatment
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
Couple inclusion criteria:
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)
Previous ovarian surgery: LOD, endometriosis surgery, ovarian cysts surgery, patients with known or suspected periovarian adhesions.
Subject with pacemaker, defibrillator or other active implant
Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
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)

Sites / Locations

CHU Saint-Pierre
CU Saint-Luc
Bicetre Hospital
Royal Derby Hospital
Liverpool Women Hospital
Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

May Health Procedure

Arm Description

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.

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Occurrence of ovulation following the procedure

Full Information

NCT ID

NCT03760926

First Posted

November 21, 2018

Last Updated

October 18, 2023

Sponsor

May Health

1. Study Identification

Unique Protocol Identification Number

NCT03760926

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 14, 2019 (Actual)

Primary Completion Date

September 2, 2023 (Actual)

Study Completion Date

October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

May Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

Anovulatory infertility

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

May Health Procedure

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

May Health Kit

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

Up to 30 days

Title

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.

Time Frame

During procedure

Secondary Outcome Measure Information:

Title

Occurrence of ovulation following the procedure

Time Frame

Up to 3 months after procedure

Other Pre-specified Outcome Measures:

Title

Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered during procedure

Time Frame

At procedure, 7 days, 30 days

Title

Usability of the May Health Kit

Time Frame

During procedure

Title

Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered post-procedure

Time Frame

At 30 days

Title

May Health Procedure time

Time Frame

During procedure

Title

Occurrence of ovulation following the procedure

Time Frame

Up to 6 months after procedure

Title

Pregnancy

Time Frame

At 3, 6, 9 12 and 24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Candidates for this study must meet ALL of the following criteria: Inclusion criteria for female participants: Age: ≥ 18 to ≤ 40 years 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) 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 Couple inclusion criteria: 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) Previous ovarian surgery: LOD, endometriosis surgery, ovarian cysts surgery, patients with known or suspected periovarian adhesions. Subject with pacemaker, defibrillator or other active implant Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saad Amer, MD, PhD

Organizational Affiliation

Derby Royal Hospital

Official's Role

Study Director

Facility Information:

Facility Name

CHU Saint-Pierre

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

CU Saint-Luc

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Bicetre Hospital

City

Le Kremlin-Bicêtre

ZIP/Postal Code

94270

Country

France

Facility Name

Royal Derby Hospital

City

Derby

ZIP/Postal Code

DE22 3NE

Country

United Kingdom

Facility Name

Liverpool Women Hospital

City

Liverpool

ZIP/Postal Code

L8 7SS

Country

United Kingdom

Facility Name

Royal Hallamshire Hospital

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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