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

Running, not enrolling · Not applicable

Conditions studied: Polycystic Ovary Syndrome, Infertility, Female

In brief

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

Key facts

Study ID

NCT06206746

Run by

May Health

People needed

195

Starts

2024-03-25

Expected to finish

2029-09-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• HRC Fertility - Encino — Encino, California, United States
• UCSF Center for Reproductive Health — San Francisco, California, United States
• University of South Florida — Tampa, Florida, United States
• The IVF Center — Winter Park, Florida, United States
• SIU School of Medicine, Reproductive Endocrinology & Infertility Center — Springfield, Illinois, United States
• University of Iowa Health Care — Iowa City, Iowa, United States
• Cypress Medical Research Center — Wichita, Kansas, United States
• Johns Hopkins Fertility Center — Lutherville, Maryland, United States
• Washington University Fertility and Reproductive Medicine Center — St Louis, Missouri, United States
• University of Rochester, Strong Fertility Center — Rochester, New York, United States
• Reach Fertility — Charlotte, North Carolina, United States
• UNC Fertility — Raleigh, North Carolina, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Penn State College of Medicine — Hershey, Pennsylvania, United States
• Penn Fertility Care — Philadelphia, Pennsylvania, United States
• Prisma Health - Upstate — Greenville, South Carolina, United States
• UT Health San Antonio — San Antonio, Texas, United States
• Baylor Scott & White Medical Center — Temple, Texas, United States
• UW Health Generations Fertility Care — Middleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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