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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206746
• Other study ID #: CR003
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: May 2028

Study information

• Verified date: March 2024
• Source: May Health
• Contact: Bertha Torres
• Phone: 7144571229
• Email: Bertha[@]Mayhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: May 2028
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 neither ovary > 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.) or functional cyst >25 mm on transvaginal ultrasound

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 (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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	UW Health Generations Fertility Care	Middleton	Wisconsin
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	University of Rochester, Strong Fertility Center	Rochester	New York
United States	The IVF Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
May Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation occurrence	Occurrence of at least one (1) ovulation	Day 0 through 3 month visit
Primary	Adverse event collection	All adverse events will be collected and analyzed for seriousness, severity, relatedness to the device and/or the procedure, and whether anticipated	Day 0 through 36 month visit
Secondary	Cumulative ovulation rate at 6 months without 1st-line	Cumulative ovulation rate at 6 months, without 1st line medication restarted = 3 months post-procedure	Device arm at 6 month visit
Secondary	Cumulative ovulation rate at 6 months with 1st-line	Cumulative ovulation rate at 6 months, with 1st line medication restarted = 3 months post-procedure	Device arm at 6 month visit
Secondary	Time to ovulation	Defined as time between Day 0 and first ovulation	Day 0 through 36 month visit
Secondary	Documented pregnancy	Documented pregnancy (biochemical or clinical) at any point during the study (participant reported or medical record)	3 month visit through 36 month visit
Secondary	Hormone serum concentrations	Anti-Müllerian hormone (AMH) serum concentration (ng/mL); Androstenedione serum concentration (ng/dL); Sex Hormone Binding Globulin (SHBG) (nmol/L); Free Androgen Index (FAI)	Baseline through 36 month visit
Secondary	Pain level after procedure	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	Device arm only - Baseline through 7 day visit
Secondary	Performance of activities of daily living	Received score from activities of daily living (ADL)	Device arm only at 24 hours post surgery through 30 day visit
Secondary	Procedure times	Includes pre-treatment, treatment, and post-treatment	Device arm only at Day 0
Secondary	Time to discharge	Defined as time from end-of-procedure until participant meets all conditions to be discharged from Post Anesthesia Care Unit (PACU)	Device arm only at Day 0
Secondary	Post Anesthetic Discharge Scoring System (PADSS)	Post Anesthetic Discharge Scoring System (PADSS) score received after procedure	Device arm only at 1 to 2 hours post procedure