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

Inclusion 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 antralfollicle count per ovary ≥ 20) OR

2.2 Evidence of hyperandrogenemia: either clinical (hirsutism defined as modifiedFerriman-Gallwey (mFG) level ≥ 4-6 depending on ethnicity) or biochemical (raisedserum concentration of androgens, testosterone ≥ 2.5 nmol/L, or FAI > 4)

3. At least one ovary with ovarian volume ≥ 10.0 mL and < 28.0 mL

4. Ovarian accessibility: determined by ability to bring transvaginal ultrasoundtransducer into close proximity to at least one ovary. (Note: In the situation whereonly one ovary is appropriately sized according to the preceding criterion, thenthis requirement applies to the qualifying ovary.)

5. At least one patent fallopian tube and normal uterine cavity as determined bysonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3years

6. Has not responded to first-line ovulation induction treatment or is contraindicatedfor, 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 theapproved written translations of the Patient Information and Informed consent form

10. Signed informed consent

Exclusion Criteria:

1. Currently pregnant

2. BMI > 40

3. Marked hyperandrogenism (total serum testosterone ≥ 4.5 nmol/L or 130ng/dL)

4. Poor glycemic level control defined as glycohemoglobin (HbA1c) level > 6.5%

5. Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use ofanticoagulation 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 surgery (e.g. ovarian drilling, ovarian cysts surgery, orendometriosis surgery on the ovary)

9. Transvaginal ultrasound transducer cannot be brought into proximity of at least oneovary

10. Presence of a pathologic cyst (i.e. endometrioma, dermoid, etc.) of any size, or afollicle, or functional cyst >15 mm on transvaginal ultrasound in ovary to betreated

11. Received > 2 cycles of treatment with gonadotropins for ovarian stimulation withouta resulting pregnancy (excludes human chorionic gonadotropin (hCG) triggerinjection)

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 requiredfor glycemic control) until the 3-month endpoint is reached

14. Male partner's total motile sperm count (TMSC) < 10 million or not available (unlessparticipant is planning donor sperm IUI)

15. Patient is currently participating in another investigational drug or device studythat clinically interferes with the endpoints of this study

16. Known or suspected gynecological malignancy

17. General health condition or systemic disease that may contribute to anovulation,infertility, or represent in the opinion of the investigator, a potential increasedrisk associated with the May Health system