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.

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)