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

May Health

Status: Enrolling

Conditions: Polycystic Ovary Syndrome; Infertility, Female

Treatments: Device: May Health System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06206746

CR003

Details and patient eligibility

About

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

Full 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.

Enrollment: 195 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.) of any size, or functional cyst >15 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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195 participants in 2 patient groups

Device arm

Experimental group

Description:

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.

Treatment:

Device: May Health System

Control arm

No Intervention group

Description:

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.