The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System
Purpose
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
Conditions
- Polycystic Ovary Syndrome
- Infertility, Female
Eligibility
- Eligible Ages
- Between 18 Years and 40 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- 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
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Device arm |
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. |
|
|
No Intervention Control arm |
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. |
|
Recruiting Locations
UCSF Center for Reproductive Health
San Francisco, California 94158
San Francisco, California 94158
The IVF Center
Winter Park, Florida 32792
Winter Park, Florida 32792
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52245
Iowa City, Iowa 52245
Cypress Medical Research Center
Wichita, Kansas 67226
Wichita, Kansas 67226
IVF Michigan, P.C.
Bloomfield Hills, Michigan 48304
Bloomfield Hills, Michigan 48304
Washington University Fertility and Reproductive Medicine Center
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Reach Fertility
Charlotte, North Carolina 28207
Charlotte, North Carolina 28207
UNC Fertility
Raleigh, North Carolina 27617
Raleigh, North Carolina 27617
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Penn State College of Medicine
Hershey, Pennsylvania 17003
Hershey, Pennsylvania 17003
Penn Fertility Care
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
UT Health San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
Baylor Scott & White Medical Center
Temple, Texas 76508
Temple, Texas 76508
UW Health Generations Fertility Care
Middleton, Wisconsin 53562
Middleton, Wisconsin 53562
More Details
- Status
- Recruiting
- Sponsor
- May Health
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.