The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System
NCT ID: NCT06206746
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
195 participants
INTERVENTIONAL
2024-03-25
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Device arm
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.
May Health System
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.
Control arm
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.
No interventions assigned to this group
Interventions
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May Health System
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.
Eligibility Criteria
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Inclusion Criteria
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
7. Currently seeking immediate fertility
8. Willing to comply with Clinical Investigation Plan-specified follow-up evaluations
9. Ability to understand study requirements and has sufficient fluency in one of the approved written translations of the Patient Information and Informed consent form
10. Signed informed consent
Exclusion Criteria
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)
9. Transvaginal ultrasound transducer cannot be brought into proximity of at least one ovary
10. 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
11. Received \> 2 cycles of treatment with gonadotropins for ovarian stimulation without a resulting pregnancy (excludes human chorionic gonadotropin (hCG) trigger injection)
12. Contraindicated to or known previous reaction to anesthesia or sedation regimen
13. 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
14. Male partner's total motile sperm count (TMSC) \< 10 million or not available (unless participant is planning donor sperm IUI)
15. Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
16. Known or suspected gynecological malignancy
17. 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
18 Years
40 Years
FEMALE
No
Sponsors
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May Health
INDUSTRY
Responsible Party
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Principal Investigators
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Karl Hansen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oklahoma University Health Sciences Center
Anuja Dokras, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn Fertility Care
Locations
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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
IVF Michigan, P.C.
Bloomfield Hills, Michigan, 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
Countries
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Central Contacts
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Facility Contacts
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Jamie Corley, BS
Role: primary
Elena Hoskin, MPH
Role: backup
Hillary Henry
Role: primary
Maha Al Jumaily, MBBS
Role: backup
Mark Trolice, MD, MBA
Role: primary
Laurel Stadtmauer, MD
Role: backup
Kathleen Groesch, MS
Role: primary
Emily Eschenbaum, BS
Role: backup
Karen M Summers, MPH
Role: primary
Bryan S Baker, BSN, MSM
Role: primary
Wes Brown
Role: backup
Karen Lynch, RN
Role: primary
Irene Trueheart
Role: backup
Beverly J Schultz, BS, BSN
Role: primary
Annalise R O'Meara, BSN
Role: backup
Dan Lebovic, MD
Role: primary
Stephanie Graham, MS
Role: primary
Chelsea Grinnan, RN
Role: primary
Anne Steiner, MD
Role: backup
Christy Zornes, MHR
Role: primary
Kyra Woods, BA
Role: backup
Robinn Moyer, BS
Role: primary
Amyee McMonagle, RN, BSN, CCRC
Role: backup
Claire Webb, MRes
Role: primary
Andrea Morley
Role: backup
Patti Parker, RN
Role: primary
Alexis Kelly, BS
Role: backup
Marisa Fernandez, BSN, RN
Role: primary
Michelle Vanecek, BS
Role: primary
Melissa Zdroik, BS
Role: backup
Gianna Gemagnani-Valoe
Role: primary
Other Identifiers
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CR003
Identifier Type: -
Identifier Source: org_study_id