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

• 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)

A regiszterben nem jelölt feltételek

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