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

A vizsgálat adatai

Ki végzi

May Health

Azonosító

NCT06206746

A regiszteradat frissítve

2026. szeptember 8.

Eredeti leírás

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 SyndromeA teljes eredeti leírásKevesebb

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

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

Bevonási feltételek: 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.

Kizáró feltételek: Previous ovarian surgery (e.g. ovarian drilling, ovarian cysts surgery, or endometriosis surgery on the ovary); 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; Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study; 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; 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; Marked hyperandrogenism (total serum testosterone ≥ 4.5 nmol/L or 130ng/dL); Poor glycemic level control defined as glycohemoglobin (HbA1c) level > 6.5%; Male partner's total motile sperm count (TMSC) < 10 million or not available (unless participant is planning donor sperm IUI); Currently pregnant; BMI > 40; Patient with known or suspected periovarian adhesions; 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.

ClinicalTrials.gov NCT06206746