Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Syndrome

Infertility

Infertility, Female

Polycystic Ovary Syndrome

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

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 fertility medication. Crossover participants who choose to crossover after the 3 month follow up visit will restart follow up as per the Device arm.

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.

May Health System

Bertha Torres

Christina Hawley, MPH

Mark Trolice, MD, MBA

Laurel Stadtmauer, MD

Laurel Stadtmauer, MD, PhD

Jayapriya Jayakumaran, MD

Lucy Chen, MD

Jessica J Brunner

Sarah Caveglia, MPH

Wendy Vitek, MD

Kathleen M Hoeger, MD, MPH

Snigdha Alur Gupta, MD

Christy Zornes, MHR

Kyra Woods, BA

Karl Hansen, MD, PhD

Heather Burks, MD

LaTasha Craig, MD

Michael Evans, DO

Meg Waltz-Peebles

Gianna Gemagnani-Valoe

Laura Cooney, MD

Aleksandar Stanic-Kostic, MD, PhD

Bala Bhagavath, MD

Anuja Dokras, MD, PhD

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

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.

Control arm has the option to crossover to receive the May Health procedure after completion of the 3 month primary endpoint visit.

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

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

Individual participant data after deidentification (text, tables, figures and appendices) in annual clinical study report

All adverse events will be collected and analyzed for seriousness, severity, relatedness to the device and/or the procedure, and whether anticipated

Cumulative ovulation rate at 6 months, without 1st line medication restarted ≥ 3 months post-procedure

Cumulative ovulation rate at 6 months, with 1st line medication restarted ≥ 3 months post-procedure

Defined as time between Day 0 and first ovulation

Documented pregnancy (biochemical or clinical) at any point during the study (participant reported or medical record)

Anti-Müllerian hormone (AMH) serum concentration (ng/mL); Androstenedione serum concentration (ng/dL); Sex Hormone Binding Globulin (SHBG) (nmol/L); Free Androgen Index (FAI)

Measured by Visual Analog Scale (VAS), immediately after procedure completion, prior to discharge, 1-, and 7-day follow-up as well as baseline pain level reported by the participant during menstruation as reference

Received score from activities of daily living (ADL)

Includes pre-treatment, treatment, and post-treatment

Defined as time from end-of-procedure until participant meets all conditions to be discharged from Post Anesthesia Care Unit (PACU)

Post Anesthetic Discharge Scoring System (PADSS) score received after procedure

May Health

AblaCare Procedure performed with use of the AblaCare Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

The intervention includes the short-term use of the AblaCare System, which is comprised of three elements: (1) the AblaCare Needle-Catheter Ablation Device (NCAD) (the Device) a 16G echogenic needle including a bipolar temperature-controlled RF ablation catheter which is clipped and secure onto a vaginal ultrasound probe; (2) the AblaCare Adapter which is clipped onto the ultrasound probe; and (3) the AblaCare Generator: a bipolar radiofrequency (RF) ablation platform utilizing the single use AblaCare NCAD for ovarian tissue ablation.

Once th patient is under conscious sedation, the physician guides the AblaCare system transvaginally with the use of a transvaginal ultrasound. Once the AblaCare device is safely and securely positioned, the physician will deliver radio frequency energy inside the ovary in order to ablate the tissue.

AblaCare System

The objective of the study is to provide preliminary evidence for the safety and effectiveness of the AblaCare System in transvaginal ablation of ovarian tissue under ultrasound visualization 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.

Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System	NCT06206746	Polycystic Ovar... Infertility, Fe...	May Health Syst...	18 Years - 40 Years	May Health
Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome	NCT05320289	Polycystic Ovar... Infertility, Fe...	AblaCare System	18 Years - 40 Years	May Health
The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System	NCT06206746	Polycystic Ovar... Infertility, Fe...	May Health Syst...	18 Years - 40 Years	May Health
Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome	NCT05320289	Polycystic Ovar... Infertility, Fe...	AblaCare System	18 Years - 40 Years	May Health

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