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

NCT06206746 | Recruiting DMC FDA Device

• 1 other identifier: CR003
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 24

Brief 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

Conditions

Polycystic Ovary Syndrome; Infertility, Female

Keywords

PCOS; Infertility related to PCOS; Ovulation restoration

Outcome Measures

Primary Outcomes (2)

• Ovulation occurrence

  Occurrence of at least one (1) ovulation

  3 month follow-up

• Adverse event collection

  Adverse events will be collected between and at each study visit after randomization and throughout the duration of the study and analyzed for seriousness, severity, relatedness to the device and/or the procedure, and whether anticipated

  Day 0 through 36 month visit

Secondary Outcomes (10)

• Cumulative ovulation rate at 6 months without 1st-line medication

  Device arm and Crossover at 6 month visit

• Cumulative ovulation rate at 6 months with 1st-line

  Device arm and Crossover at 6 month visit

• Time to ovulation

  Baseline for the control group is day of randomization to the date of first ovulation. Baseline for the treatment group is day of procedure to the date of first ovulation

• Documented pregnancy

  Control Arm, Device Arm, and Crossover group: from baseline to 30 Day, 3 Month; Device Arm and Crossover group only: 6 Month, 12 Month, 24 Month, 36 Month

• Hormone serum concentrations

  Baseline through 36 month visit

Study Arms (2)

Device arm

EXPERIMENTAL

May Health procedure performed with the use of the May Health system intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to Polycystic Ovary Syndrome.

Device: May Health System

Control arm

NO INTERVENTION

No fertility medication. Crossover participants who choose to crossover after the 3 month follow up visit will restart follow up as per the Device arm.

Interventions

May Health System DEVICE

The intervention includes the short-term use of the May Health System, which is comprised of three elements: (1) the May Health Needle-Catheter Ablation Device (NCAD) (the Device) a 16 gauge echogenic needle including a bipolar temperature-controlled RF ablation catheter which is clipped and secured onto a vaginal ultrasound probe; (2) the May Health Adapter which is clipped onto the ultrasound probe; and (3) the May Health Generator: a bipolar radiofrequency (RF) ablation platform utilizing the single use May Health NCAD for ovarian tissue ablation. Once the patient is under conscious sedation, the physician guides the May Health system transvaginally with the use of a transvaginal ultrasound. Once the May Health device is safely and securely positioned, the physician will deliver radio frequency energy inside the ovary in order to ablate the tissue.

Device arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 to ≤ 40 years
• Infertility associated with oligo- or anovulation, AND EITHER:
• Ultrasonographic evidence of PCOS (ovarian volume ≥ 10 mL and/or ovarian antral follicle count per ovary ≥ 20) OR
• 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

Sponsors & Collaborators

• May Health: lead

Study Sites (24)

HRC Fertility - Encino

Encino, California, 91436, United States

RECRUITING

UCSF Center for Reproductive Health

San Francisco, California, 94158, United States

RECRUITING

Florida Fertility Institute

Clearwater, Florida, 33759, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

The IVF Center

Winter Park, Florida, 32792, United States

RECRUITING

SIU School of Medicine, Reproductive Endocrinology & Infertility Center

Springfield, Illinois, 62702, United States

RECRUITING

University of Iowa Health Care

Iowa City, Iowa, 52240, United States

RECRUITING

Cypress Medical Research Center

Wichita, Kansas, 67226, United States

RECRUITING

Johns Hopkins Fertility Center

Lutherville, Maryland, 21093, United States

RECRUITING

UMass Memorial Medical Center / UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

RECRUITING

IVF Michigan, P.C.

Bloomfield Hills, Michigan, 48304, United States

WITHDRAWN

Washington University Fertility and Reproductive Medicine Center

St Louis, Missouri, 63110, United States

RECRUITING

University Reproductive Associates, PC

Hasbrouck Heights, New Jersey, 07604, United States

RECRUITING

University of Rochester, Strong Fertility Center

Rochester, New York, 14623, United States

ACTIVE NOT RECRUITING

Reach Fertility

Charlotte, North Carolina, 28207, United States

ACTIVE NOT RECRUITING

UNC Fertility

Raleigh, North Carolina, 27617, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Penn State College of Medicine

Hershey, Pennsylvania, 17003, United States

RECRUITING

Penn Fertility Care

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Prisma Health - Upstate

Greenville, South Carolina, 29605, United States

RECRUITING

UT Health San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Baylor Scott & White Medical Center

Temple, Texas, 76508, United States

RECRUITING

UW Health Generations Fertility Care

Middleton, Wisconsin, 53562, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility, Female

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Infertility

Study Officials

• Karl Hansen, MD, PhD

  Oklahoma University Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Anuja Dokras, MD, PhD

  Penn Fertility Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertha Torres

CONTACT

7144571229; Bertha@Mayhealth.com

Tracy Rodriguez

CONTACT

Tracy@mayhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Control arm has the option to crossover to receive the May Health procedure after completion of the 3 month primary endpoint visit.

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 16, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Annually, beginning 3 months following FDA submission of annual report, ending 6 months after final report.
• Access Criteria: Investigators participating in the study who have been approved by an institutional review board.

Locations

US (24)