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

Polycystic Ovary Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03760926
• Other study ID #: ULTRA
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2019
• Est. completion date: October 1, 2025

Study information

• Verified date: October 2023
• Source: May Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: October 1, 2025
• Est. primary completion date: September 2, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Belgium	CHU Saint-Pierre	Bruxelles
Belgium	CU Saint-Luc	Bruxelles
France	Bicetre Hospital	Le Kremlin-Bicêtre
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	Liverpool Women Hospital	Liverpool
United Kingdom	Royal Hallamshire Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
May Health

Countries where clinical trial is conducted

Belgium,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Usability of the May Health Kit		During procedure
Other	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
Other	May Health Procedure time		During procedure
Other	Occurrence of ovulation following the procedure		Up to 6 months after procedure
Other	Pregnancy		At 3, 6, 9 12 and 24 months
Primary	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
Primary	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	Occurrence of ovulation following the procedure		Up to 3 months after procedure