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

The objective of the study is to provide evidence for the safety and effectiveness of the May Health System in transvaginal ablation of ovarian tissue under transvaginal ultrasound guidance to restore ovulation in women with infertility due to polycystic ovary syndrome (PCOS) who have not responded to first-line ovulation induction treatment or are contraindicated for or decline such treatment.

Inclusion criteria

• Age ≥ 18 to ≤ 40 years
• 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)

• 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

Exclusion criteria

• Currently pregnant
• BMI > 40
• Marked hyperandrogenism (total serum testosterone ≥ 4.5 nmol/L or 130ng/dL)
• Poor glycemic level control defined as glycohemoglobin (HbA1c) level > 6.5%
• Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use of anticoagulation medication, etc.
• Active genital or urinary tract infection at the time of the procedure
• Patient with known or suspected periovarian adhesions
• Previous ovarian surgery (e.g. ovarian drilling, ovarian cysts surgery, or endometriosis surgery on the ovary)
• Transvaginal ultrasound transducer cannot be brought into proximity of at least one ovary
• Presence of a pathologic cyst (i.e. endometrioma, dermoid, etc.) of any size, or a follicle, or functional cyst >15 mm on transvaginal ultrasound in ovary to be treated
• Received > 2 cycles of treatment with gonadotropins for ovarian stimulation without a resulting pregnancy (excludes human chorionic gonadotropin (hCG) trigger injection)
• Contraindicated to or known previous reaction to anesthesia or sedation regimen
• 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
• Male partner's total motile sperm count (TMSC) < 10 million or not available (unless participant is planning donor sperm IUI)
• Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
• Known or suspected gynecological malignancy
• General health condition or systemic disease that may contribute to anovulation, infertility, or represent in the opinion of the investigator, a potential increased risk associated with the May Health system