The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

Eligibility Criteria

• 1. Age ≥ 18 to ≤ 40 years
• 2. Infertility associated with oligo- or anovulation, AND EITHER:
• 2.1 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10 mL and/or ovarian antral follicle count per ovary ≥ 20) OR
• 2.2 Evidence of hyperandrogenemia: either clinical (hirsutism defined as modified Ferriman-Gallwey (mFG) level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens, testosterone ≥ 2.5 nmol/L, or FAI \> 4)
• 3. At least one ovary with ovarian volume ≥ 10.0 mL and neither ovary \> 23.0 mL
• 4. Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to at least one ovary. (Note: In the situation where only one ovary is appropriately sized according to the preceding criterion, then this requirement applies to the qualifying ovary.)
• 5. At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
• 6. Has not responded to first-line ovulation induction treatment or is contraindicated for, or declines, such treatment
• 7. Currently seeking immediate fertility
• 8. Willing to comply with Clinical Investigation Plan-specified follow-up evaluations
• 9. Ability to understand study requirements and has sufficient fluency in one of the approved written translations of the Patient Information and Informed consent form
• 10. Signed informed consent
• 1. Currently pregnant
• 2. BMI \> 40
• 3. Marked hyperandrogenism (FAI \> 15)
• 4. Poor glycemic level control defined as glycohemoglobin (HbA1c) level \> 6.5%
• 5. Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use of anticoagulation medication, etc.
• 6. Active genital or urinary tract infection at the time of the procedure
• 7. Patient with known or suspected periovarian adhesions
• 8. Previous ovarian or tubal surgery such as ovarian drilling, endometriosis surgery, ovarian cysts surgery or sterilization procedure (i.e., tubal ligation)
• 9. Transvaginal ultrasound transducer cannot be brought into proximity of at least one ovary
• 10. Presence of a pathologic cyst (i.e. endometrioma, dermoid, etc.) of any size, or functional cyst \>15 mm on transvaginal ultrasound
• 11. Received \> 2 cycles of treatment with gonadotropins without a resulting pregnancy
• 12. Contraindicated to or known previous reaction to anesthesia or sedation regimen
• 13. Patient not willing to stop all concomitant first-line ovulation induction treatment (clomiphene citrate, letrozole, as well as metformin unless metformin is required for glycemic control) until the 3-month endpoint is reached
• 14. Male partner's total motile sperm count (TMSC) \< 10 million (unless participant is planning donor sperm IUI)
• 15. Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study