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

Launched by MAY HEALTH · Jan 4, 2024

Keywords

ClinConnect Summary

The REBALANCE Study is a clinical trial designed to explore a new treatment option for women aged 18 to 40 who are struggling with infertility due to Polycystic Ovary Syndrome (PCOS). This study will investigate the use of a procedure called transvaginal ablation, which involves using ultrasound guidance to treat ovarian tissue. Eligible participants must have specific signs of PCOS and infertility, such as irregular ovulation or high levels of male hormones. They should also have at least one functioning ovary and a clear fallopian tube.

If you decide to participate, you will receive close monitoring and follow-up evaluations throughout the study. This trial aims to provide new insights into fertility treatments for women with PCOS, especially those who have not responded to standard treatments. It's important to know that certain conditions, like being currently pregnant or having a high body mass index, may prevent you from joining the study. Overall, the REBALANCE Study hopes to help improve fertility options for women facing these challenges.

Gender

FEMALE

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