The REBALANCE Study - a Study of the May Health System in women with infertility

Is the device called the May Health System safe and effective in women with infertility?

Lead Researcher: Wendy Vitek

The purpose of this research is to investigate the safety and effectiveness of an investigational medical device for the treatment of infertility in women with polycystic ovary syndrome (PCOS). You may be eligible for this study if you are 18 - 40 years old and are infertile with evidence of PCOS. Other criteria may apply.

More Details:

• https://clinicaltrials.gov/ct2/show/NCT06206746

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