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

Inclusion Criteria

• •Candidates for this study must meet ALL of the following criteria:
• •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
• •8. Normal sperm parameters based on WHO 2000 criteria (concentration⩾ 15 million/mL, motility A+B ⩾ 32%, normal forms ⩾ 4%).
• +10 more criteria