Actively Recruiting
A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue Under Ultrasound Guidance for Infertility Due to Polycystic Ovary Syndrome
Led by May Health · Updated on 2026-05-08
195
Participants Needed
24
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the May Health System, a device used for transvaginal ablation of ovarian tissue under ultrasound guidance, to restore ovulation in women with infertility caused by polycystic ovary syndrome (PCOS). This study focuses on women who have not responded to first-line ovulation induction treatments or cannot use them due to contraindications or personal choice. The trial aims to provide evidence for the safety and effectiveness of this approach in improving ovulation and fertility outcomes. The study includes two groups: one receiving the May Health procedure, which involves using a special needle-catheter device guided by ultrasound to deliver radiofrequency energy to ablate ovarian tissue, and a control group receiving no fertility medication. Participants who do not become pregnant after three months may cross over to receive the device treatment and follow the same monitoring schedule. The procedure is done under conscious sedation and involves close ultrasound visualization. Participants will be involved in follow-up visits for up to 36 months to monitor ovulation occurrence, pregnancy, hormone levels, pain after the procedure, and recovery activities. Researchers will also collect safety data throughout this period. Various assessments include timing ovulation, measuring hormone serum concentrations, and evaluating post-procedure pain and daily activity performance. The study helps track both short-term and long-term outcomes related to fertility and safety.
CONDITIONS
Brief Title
The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 40 years
- Infertility linked to oligo- or anovulation with either ultrasonographic evidence of PCOS or clinical/biochemical hyperandrogenemia
- At least one ovary sized between 10.0 mL and less than 28.0 mL
- Ability to bring transvaginal ultrasound transducer close to at least one ovary
- At least one open fallopian tube and normal uterine cavity confirmed within last 3 years
- Has not responded to or is contraindicated for or declines first-line ovulation induction treatment
- Currently seeking immediate fertility
- Willing to comply with study follow-up evaluations
- Able to understand study requirements and provide informed consent
You will not qualify if you...
- Currently pregnant
- Body mass index greater than 40
- Marked hyperandrogenism with total serum testosterone 4.5 nmol/L or higher
- Poor blood sugar control with HbA1c greater than 6.5%
- Bleeding disorders or current use of blood thinners
- Active genital or urinary tract infection at procedure time
- Known or suspected periovarian adhesions
- Previous ovarian surgery
- Inability to position ultrasound transducer near ovary
- Presence of pathological or functional ovarian cysts larger than 15 mm
- More than two unsuccessful cycles of gonadotropin treatment for ovarian stimulation
- Contraindications or previous reactions to anesthesia or sedation
- Unwillingness to stop first-line ovulation induction treatment until 3-month endpoint
- Male partner's total motile sperm count below 10 million unless donor sperm is planned
- Participation in another interfering investigational drug or device study
- Known or suspected gynecological cancer
- Any health condition posing increased risk with the May Health system procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo the May Health System procedure which involves transvaginal ablation of ovarian tissue under ultrasound guidance using the May Health System device while under conscious sedation.
1 procedure visit (in-person)
Duration - Up to 36 months
Participants are monitored for safety and effectiveness including ovulation occurrence, adverse events, hormone levels, pain, and daily activity performance after the procedure.
Multiple visits including 3 month, 6 month, 12 month, 24 month, and 36 month follow-up visits
Trial Site Locations
Total: 24 locations
1
HRC Fertility - Encino
Encino, California, United States, 91436
Actively Recruiting
2
UCSF Center for Reproductive Health
San Francisco, California, United States, 94158
Actively Recruiting
3
Florida Fertility Institute
Clearwater, Florida, United States, 33759
Actively Recruiting
4
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
5
The IVF Center
Winter Park, Florida, United States, 32792
Actively Recruiting
6
SIU School of Medicine, Reproductive Endocrinology & Infertility Center
Springfield, Illinois, United States, 62702
Actively Recruiting
7
University of Iowa Health Care
Iowa City, Iowa, United States, 52240
Actively Recruiting
8
Cypress Medical Research Center
Wichita, Kansas, United States, 67226
Actively Recruiting
9
Johns Hopkins Fertility Center
Lutherville, Maryland, United States, 21093
Actively Recruiting
10
UMass Memorial Medical Center / UMass Chan Medical School
Worcester, Massachusetts, United States, 01605
Actively Recruiting
11
IVF Michigan, P.C.
Bloomfield Hills, Michigan, United States, 48304
Withdrawn
12
Washington University Fertility and Reproductive Medicine Center
St Louis, Missouri, United States, 63110
Active, Not Recruiting
13
University Reproductive Associates, PC
Hasbrouck Heights, New Jersey, United States, 07604
Actively Recruiting
14
University of Rochester, Strong Fertility Center
Rochester, New York, United States, 14623
Active, Not Recruiting
15
Reach Fertility
Charlotte, North Carolina, United States, 28207
Active, Not Recruiting
16
UNC Fertility
Raleigh, North Carolina, United States, 27617
Actively Recruiting
17
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
18
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
19
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17003
Actively Recruiting
20
Penn Fertility Care
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
21
Prisma Health - Upstate
Greenville, South Carolina, United States, 29605
Actively Recruiting
22
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
23
Baylor Scott & White Medical Center
Temple, Texas, United States, 76508
Actively Recruiting
24
UW Health Generations Fertility Care
Middleton, Wisconsin, United States, 53562
Actively Recruiting
Research Team
B
Bertha Torres
T
Tracy Rodriguez
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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