The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System (NCT06206746) | Clinical Trial Compass
RecruitingNot Applicable
The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System
United States195 participantsStarted 2024-03-25
Plain-language summary
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
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. 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