Actively Recruiting
The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System
Led by May Health · Updated on 2026-05-08
195
Participants Needed
24
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 with oligo- or anovulation and either ultrasound evidence of PCOS or clinical/biochemical signs of hyperandrogenemia
- At least one ovary with volume between 10.0 mL and less than 28.0 mL
- Ability to bring the transvaginal ultrasound probe close to at least one ovary
- At least one patent fallopian tube and normal uterine cavity confirmed within the last 3 years
- No response to first-line ovulation induction treatment or contraindicated for or declined such treatment
- Currently seeking immediate fertility
- Willing to comply with follow-up evaluations specified in the study plan
- Ability to understand study requirements and fluent in approved language for informed consent
- Signed informed consent form
You will not qualify if you...
- Currently pregnant
- Body mass index over 40
- Marked hyperandrogenism with total serum testosterone 4.5 nmol/L or higher
- Poor glycemic control with HbA1c over 6.5%
- Bleeding disorders or current use of anticoagulant medications
- Active genital or urinary tract infection at procedure time
- Known or suspected periovarian adhesions
- Previous ovarian surgery such as drilling or cyst removal
- Transvaginal ultrasound probe cannot reach at least one ovary
- Presence of pathologic cysts or follicles larger than 15 mm in ovary to be treated
- More than two cycles of gonadotropin treatment without pregnancy
- Contraindications or prior reactions to anesthesia or sedation
- Unwilling to stop first-line ovulation induction treatments until 3-month endpoint
- Male partner's total motile sperm count less than 10 million or unavailable unless using donor sperm
- Current participation in another conflicting investigational study
- Known or suspected gynecological cancer
- Other health conditions posing increased risk or contributing to infertility as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
T
Tracy Rodriguez
CONTACT
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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