Trial Title:
The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System
NCT ID:
NCT06206746
Condition:
Polycystic Ovary Syndrome
Infertility, Female
Conditions: Official terms:
Polycystic Ovary Syndrome
Infertility
Infertility, Female
Syndrome
Conditions: Keywords:
PCOS
Infertility related to PCOS
Ovulation restoration
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
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)
Intervention:
Intervention type:
Device
Intervention name:
May Health System
Description:
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.
Arm group label:
Device arm
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
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.
Criteria for 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 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UCSF Center for Reproductive Health
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jamie Corley, BS
Email:
jamie.corley@ucsf.edu
Contact backup:
Last name:
Elena Hoskin, MPH
Email:
elena.hoskin@ucsf.edu
Investigator:
Last name:
Heather Huddleston, MD
Email:
Principal Investigator
Investigator:
Last name:
Marcelle Cedars, MD
Email:
Sub-Investigator
Facility:
Name:
The IVF Center
Address:
City:
Winter Park
Zip:
32792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mark Trolice, MD, MBA
Phone:
407-672-1106
Email:
drtrolice@theivfcenter.com
Contact backup:
Last name:
Laurel Stadtmauer, MD
Phone:
407-672-1106
Email:
drstadtmauer@theivfcenter.com
Investigator:
Last name:
Laurel Stadtmauer, MD, PhD
Email:
Principal Investigator
Facility:
Name:
University of Iowa Hospitals and Clinics
Address:
City:
Iowa City
Zip:
52245
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen M Summers, MPH
Email:
karen-summers@uiowa.edu
Investigator:
Last name:
Rachel B Mejia, DO
Email:
Principal Investigator
Investigator:
Last name:
Abigail C Mancuso, MD
Email:
Sub-Investigator
Facility:
Name:
Cypress Medical Research Center
Address:
City:
Wichita
Zip:
67226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bryan S Baker, BSN, MSM
Phone:
316-425-6333
Email:
Bryan@cypressmrc.com
Contact backup:
Last name:
Wes Brown
Phone:
316-425-6333
Email:
Wbrown@cypressmrc.com
Investigator:
Last name:
David A Grainger, MD, MPH
Email:
Principal Investigator
Investigator:
Last name:
Jamie Peregrine, MD
Email:
Sub-Investigator
Facility:
Name:
University of Rochester, Strong Fertility Center
Address:
City:
Rochester
Zip:
14623
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica J Brunner
Phone:
585-487-3474
Email:
Jessica_Brunner@urmc.rochester.edu
Contact backup:
Last name:
Ikra Razak
Phone:
585-487-3378
Email:
Ikra_Razak@urmc.rochester.edu
Investigator:
Last name:
Wendy Vitek, MD
Email:
Principal Investigator
Investigator:
Last name:
Kathleen M Hoeger, MD, MPH
Email:
Sub-Investigator
Investigator:
Last name:
Snigdha Alur Gupta, MD
Email:
Sub-Investigator
Facility:
Name:
UNC Fertility
Address:
City:
Raleigh
Zip:
27617
Country:
United States
Status:
Recruiting
Contact:
Last name:
Chelsea Grinnan, RN
Phone:
919-908-0000
Email:
pcos_study@unc.edu
Contact backup:
Last name:
Anne Steiner, MD
Phone:
919-908-0000
Email:
pcos_study@unc.edu
Investigator:
Last name:
Anne Steiner, MD
Email:
Principal Investigator
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christy Zornes, MHR
Phone:
405-271-8001
Phone ext:
48137
Email:
christy-zornes@ouhsc.edu
Contact backup:
Last name:
Kyra Woods, BA
Phone:
405-271-8001
Phone ext:
45750
Email:
kyra-woods@ouhsc.edu
Investigator:
Last name:
Karl Hansen, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Heather Burks, MD
Email:
Sub-Investigator
Investigator:
Last name:
LaTasha Craig, MD
Email:
Sub-Investigator
Investigator:
Last name:
Michael Evans, DO
Email:
Sub-Investigator
Facility:
Name:
Penn Fertility Care
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Claire Webb, MRes
Phone:
215-615-4889
Email:
claire.webb@pennmedicine.upenn.edu
Contact backup:
Last name:
Andrea Morley
Phone:
215-615-4202
Email:
andrea.morley@pennmedicine.upenn.edu
Investigator:
Last name:
Anuja Dokras, MD, PhD, MHCI
Email:
Principal Investigator
Investigator:
Last name:
Christos Coutifaris, MD, PhD
Email:
Sub-Investigator
Facility:
Name:
UW Health Generations Fertility Care
Address:
City:
Middleton
Zip:
53562
Country:
United States
Status:
Recruiting
Contact:
Last name:
Meg Waltz-Peebles
Phone:
608-262-6519
Email:
waltzpeebles@wisc.edu
Contact backup:
Last name:
Gianna Gemagnani-Valoe
Phone:
608-265-1303
Email:
gemignanival@wisc.edu
Investigator:
Last name:
Laura Cooney, MD
Email:
Principal Investigator
Investigator:
Last name:
Aleksandar Stanic-Kostic, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Bala Bhagavath, MD
Email:
Sub-Investigator
Start date:
March 25, 2024
Completion date:
May 2028
Lead sponsor:
Agency:
May Health
Agency class:
Industry
Source:
May Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06206746
