Clinical trial NCT06206746: The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Infertility, Female
Keywords: PCOS
Infertility related to PCOS
Ovulation restoration
Lead sponsor: May Health
Sponsor class: INDUSTRY
First posted: 2024-01-16
Enrollment: 195
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Control arm has the option to crossover to receive the May Health procedure after completion of the 3 month primary endpoint visit.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 to ≤ 40 years
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 \< 23.0 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:

1. Currently pregnant
2. BMI \> 40
3. Marked hyperandrogenism (FAI \> 15)
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 or tubal surgery such as ovarian drilling, endometriosis surgery, ovarian cysts surgery or sterilization procedure (i.e., tubal ligation)
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 without a resulting pregnancy
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

Primary outcomes:
measure: Ovulation occurrence
timeFrame: Day 0 through 3 month visit
measure: Adverse event collection
timeFrame: Day 0 through 36 month visit
Secondary outcomes:
measure: Cumulative ovulation rate at 6 months without 1st-line
timeFrame: Device arm at 6 month visit
measure: Cumulative ovulation rate at 6 months with 1st-line
timeFrame: Device arm at 6 month visit
measure: Time to ovulation
timeFrame: Day 0 through 36 month visit
measure: Documented pregnancy
timeFrame: 3 month visit through 36 month visit
measure: Hormone serum concentrations
timeFrame: Baseline through 36 month visit
measure: Pain level after procedure
timeFrame: Device arm only - Baseline through 7 day visit
measure: Performance of activities of daily living
timeFrame: Device arm only at 24 hours post surgery through 7 days
measure: Procedure times
timeFrame: Device arm only at Day 0
measure: Time to discharge
timeFrame: Device arm only at Day 0
measure: Post Anesthetic Discharge Scoring System (PADSS)
timeFrame: Device arm only at 1 to 2 hours post procedure
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Center for Reproductive Health
state: California
city: Winter Park
country: United States
facility: The IVF Center
state: Florida
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Wichita
country: United States
facility: Cypress Medical Research Center
state: Kansas
city: Bloomfield Hills
country: United States
facility: IVF Michigan, P.C.
state: Michigan
city: Saint Louis
country: United States
facility: Washington University Fertility and Reproductive Medicine Center
state: Missouri
city: Rochester
country: United States
facility: University of Rochester, Strong Fertility Center
state: New York
city: Charlotte
country: United States
facility: Reach Fertility
state: North Carolina
city: Raleigh
country: United States
facility: UNC Fertility
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Fertility Care
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center
state: Texas
city: Middleton
country: United States
facility: UW Health Generations Fertility Care
state: Wisconsin
Study officials:
affiliation: Oklahoma University Health Sciences Center
name: Karl Hansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn Fertility Care
name: Anuja Dokras, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: