The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System
- Conditions
- Infertility, FemalePolycystic Ovary Syndrome
- Interventions
- Device: May Health System
- Registration Number
- NCT06206746
- Lead Sponsor
- May Health
- 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
- Detailed Description
The objective of the study is to provide evidence for the safety and effectiveness of the May Health System in transvaginal ablation of ovarian tissue under transvaginal ultrasound guidance to restore ovulation in women with infertility due to polycystic ovary syndrome (PCOS) who have not responded to first-line ovulation induction treatment or are contraindicated for or decline such treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 195
-
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 < 23.0 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
- Currently pregnant
- BMI > 40
- Marked hyperandrogenism (FAI > 15)
- 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 or tubal surgery such as ovarian drilling, endometriosis surgery, ovarian cysts surgery or sterilization procedure (i.e., tubal ligation)
- 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 without a resulting pregnancy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Device arm May Health System 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.
- Primary Outcome Measures
Name Time Method Ovulation occurrence Day 0 through 3 month visit Occurrence of at least one (1) ovulation
Adverse event collection Day 0 through 36 month visit 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
- Secondary Outcome Measures
Name Time Method Post Anesthetic Discharge Scoring System (PADSS) Device arm only at 1 to 2 hours post procedure Post Anesthetic Discharge Scoring System (PADSS) score received after procedure
Cumulative ovulation rate at 6 months without 1st-line Device arm at 6 month visit Cumulative ovulation rate at 6 months, without 1st line medication restarted ≥ 3 months post-procedure
Pain level after procedure Device arm only - Baseline through 7 day visit Measured by Visual Analog Scale (VAS), immediately after procedure completion, prior to discharge, 1-, and 7-day follow-up as well as baseline pain level reported by the participant during menstruation as reference
Procedure times Device arm only at Day 0 Includes pre-treatment, treatment, and post-treatment
Time to discharge Device arm only at Day 0 Defined as time from end-of-procedure until participant meets all conditions to be discharged from Post Anesthesia Care Unit (PACU)
Cumulative ovulation rate at 6 months with 1st-line Device arm at 6 month visit Cumulative ovulation rate at 6 months, with 1st line medication restarted ≥ 3 months post-procedure
Time to ovulation Day 0 through 36 month visit Defined as time between Day 0 and first ovulation
Documented pregnancy 3 month visit through 36 month visit Documented pregnancy (biochemical or clinical) at any point during the study (participant reported or medical record)
Performance of activities of daily living Device arm only at 24 hours post surgery through 7 days Received score from activities of daily living (ADL)
Hormone serum concentrations Baseline through 36 month visit Anti-Müllerian hormone (AMH) serum concentration (ng/mL); Androstenedione serum concentration (ng/dL); Sex Hormone Binding Globulin (SHBG) (nmol/L); Free Androgen Index (FAI)
Trial Locations
- Locations (16)
Prisma Health - Upstate
🇺🇸Greenville, South Carolina, United States
UCSF Center for Reproductive Health
🇺🇸San Francisco, California, United States
The IVF Center
🇺🇸Winter Park, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Cypress Medical Research Center
🇺🇸Wichita, Kansas, United States
IVF Michigan, P.C.
🇺🇸Bloomfield Hills, Michigan, United States
Washington University Fertility and Reproductive Medicine Center
🇺🇸Saint 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
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