Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome (ULTRA-US)

This is an interventional device feasibility trial for Polycystic Ovary Syndrome focused on measuring PCOS, Infertility related to PCOS, Ovulation restoration Read More

Inclusion Criteria:

1. Age: ≥ 18 to ≤ 40 years

2. Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria: Infertility associated with chronic anovulation or oligomenorrhea, AND EITHER:

   2.1. Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or ovarian antral follicle count per ovary ≥ 20) OR 2.2. Evidence of hyperandrogenaemia: either clinical (hirsutism defined as mFG level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens (testosterone ≥ 2.5nmol/l, or FAI > 4)

3. At least one ovary with ovarian volume ≥ 10ml
4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
5. Failure to respond to first-line pharmacological treatment or is contraindicated for or decline such treatment.
6. At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
7. Willing to comply with Clinical Investigation Plan-specified follow-up evaluation
8. Ability to understand study requirements and has sufficient fluency in one of the IRB-approved written translation of the Patient Information and Informed consent form
9. Signed informed consent
10. Normal sperm parameters based on WHO 2010 criteria (concentration ≥ 15 million/mL, total motility ≥ 40%, normal morphology ≥ 4%) within the last year
11. Ability to have regular vaginal intercourse during the study
12. No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed

Exclusion Criteria:

1. Current pregnancy
2. Marked obesity, BMI > 40
3. Marked hyperandrogenism (FAI > 15)
4. Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
5. Patient not willing to stop all concomitant first-line oral medications at least 6 weeks prior to study procedure and until the 3-month endpoint is reached, and all other forms of ovulation-induction treatment until the 6-month endpoint is reached
6. Lack of capacity to give informed consent
7. Lack of capacity to follow Clinical Investigation Plan and study requirements including all study follow-up visits
8. Previous ovarian surgery: laparoscopic ovarian drilling, endometriosis surgery, ovarian cysts surgery
9. Patient with known or suspected periovarian adhesions
10. Transvaginal ultrasound transducer cannot be brought into proximity of both ovaries