• Age ≥ 18 to ≤ 40 years

• Infertility associated with oligo- or anovulation, AND EITHER:

‣ 1 Ultrasonographic evidence of PCOS (ovarian volume ≥ 10 mL and/or ovarian antral follicle count per ovary ≥ 20) OR

‣ 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)

• At least one ovary with ovarian volume ≥ 10.0 mL and \< 28.0 mL

• 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.)

• At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years

• Has not responded to first-line ovulation induction treatment or is contraindicated for, or declines, such treatment

• Currently seeking immediate fertility

• Willing to comply with Clinical Investigation Plan-specified follow-up evaluations

• Ability to understand study requirements and has sufficient fluency in one of the approved written translations of the Patient Information and Informed consent form

⁃ Signed informed consent