The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

Conditions

• Infertility, Female
• Polycystic Ovary Syndrome

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

• May Health System — DEVICE
  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.

Study Details

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

Key Dates

Start date

Mar 25, 2024

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Sep 30, 2029

Study Design

Enrollment

195 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Ovulation occurrence [ Time Frame: 3 month follow-up ]

Central Contacts

• Bertha Torres
  7144571229
  [email protected]
• Tracy Rodriguez
  [email protected]

Locations (24)

Find similar trials in Encino, CA

Related Studies

• The Physiological Responses and Adaptation of Brown Adipose Tissue to Chronic Treatment With Beta3-Adrenergic Receptor Agonists
  PHASE1 · Recruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland
• IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer
  Recruiting · Bruce Rose, MD · Jacksonville, Florida
• Preimplantation Genetic Testing in Women of Advanced Maternal Age
  Recruiting · Genomic Prediction Inc. · Margate, Florida
• Apple Women's Health Study
  Recruiting · Apple Inc. · Boston, Massachusetts