RecruitingPolycystic Ovary SyndromeInfertility, Female

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

Eligible age

18–40 yrs

Accepts

Women

Locations

18 states

Healthy volunteers

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Answer a few quick questions about your location and health. Takes about a minute.

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About this study

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome

Sponsor: May Health

You may qualify if…

✓ 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 \< 28.0 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

You may not qualify if…

✕ 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 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 surgery (e.g. ovarian drilling, ovarian cysts surgery, or endometriosis surgery on the ovary)