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Procedure

Device arm for Polycystic Ovary Syndrome

N/A

Recruiting

Led By Karl Hansen, MD, PhD

Research Sponsored by May Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 to ≤ 40 years

At least one ovary with ovarian volume ≥ 10.0 mL and neither ovary > 23.0 mL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month visit through 36 month visit

Awards & highlights

Study Summary

This trial is studying the use of a new procedure called transvaginal ablation of ovarian tissue to treat infertility in women with polycystic ovary syndrome. The study is being done at

Who is the study for?

Women aged 18-40 with infertility due to PCOS, who have not responded to first-line treatments or cannot use them. Participants must have at least one accessible ovary and a normal uterine cavity, be currently seeking fertility, and agree to study follow-ups. Exclusions include pregnancy, BMI over 40, severe hyperandrogenism, poor glycemic control, bleeding disorders, active infections around the genital area, previous significant ovarian or tubal surgery.Check my eligibility

What is being tested?

The May Health System is being tested for its effectiveness in transvaginal ablation of ovarian tissue under ultrasound guidance in women with infertility related to Polycystic Ovary Syndrome (PCOS). This pivotal study randomly assigns participants to receive this intervention or a comparison treatment.See study design

What are the potential side effects?

Potential side effects may include discomfort from the procedure itself such as cramping or pain during and after the ablation process. There might also be risks associated with anesthesia used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old.

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One of my ovaries is at least 10 mL but not larger than 23 mL in volume.

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I did not respond to initial fertility treatments or cannot or choose not to take them.

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A doctor can easily reach at least one of my ovaries with an ultrasound probe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 month visit through 36 month visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 month visit through 36 month visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month visit through 36 month visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse event collection

Ovulation occurrence

Secondary outcome measures

Cumulative ovulation rate at 6 months with 1st-line

Cumulative ovulation rate at 6 months without 1st-line

Documented pregnancy

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Device armExperimental Treatment1 Intervention

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.

Group II: Control armActive Control1 Intervention

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

May HealthLead Sponsor

2 Previous Clinical Trials

33 Total Patients Enrolled

2 Trials studying Polycystic Ovary Syndrome

33 Patients Enrolled for Polycystic Ovary Syndrome

Karl Hansen, MD, PhDPrincipal InvestigatorOklahoma University Health Sciences Center

Anuja Dokras, MD, PhDPrincipal InvestigatorPenn Fertility Care

1 Previous Clinical Trials

40 Total Patients Enrolled

1 Trials studying Polycystic Ovary Syndrome

40 Patients Enrolled for Polycystic Ovary Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the number of individuals participating in this clinical investigation?

"Indeed, the data on clinicaltrials.gov verifies that this ongoing clinical trial is actively seeking participants. The initial posting date was January 15th, 2024, and it was last updated on January 4th, 2024. This study aims to enroll a total of 195 individuals from two designated sites."

Answered by AI

Are there any open slots available for new patients to participate in this research study at the moment?

"Indeed, as per the information available on clinicaltrials.gov, this research study is currently seeking eligible participants. The initial posting date for this trial was January 15th, 2024, and it received its most recent update on January 4th, 2024."

Answered by AI

What are the intended results that researchers hope to achieve through this medical study?

"As per May Health, the study sponsor, adverse event collection will be the primary outcome measured from Day 0 through the 3-month visit. The secondary outcomes to be assessed include procedure times (including pre-treatment, treatment, and post-treatment), time to discharge (defined as the duration from end-of-procedure until all conditions for discharge from Post Anesthesia Care Unit [PACU] are met), and cumulative ovulation rate at 6 months without first-line medication restarted (defined as the cumulative ovulation rate at 6 months without restarting first-line medication for a minimum of 3 months after the procedure)."

Answered by AI

Is the age criterion for participating in this research limited to individuals below 55 years of age?

"To be eligible for this clinical trial, potential participants must fall within the age range of 18 to 40. It is noteworthy that there are a total of 398 studies specifically designed for individuals under the age of 18 and an additional 1044 studies catered towards those above the age of 65."

Answered by AI

Is it possible for me to be enrolled as a participant in this medical study?

"In order to be eligible for this clinical trial, individuals must meet the diagnostic criteria for polycystic ovary syndrome (PCOS) and fall within the age range of 18 to 40 years. The study aims to enroll a total of 195 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06206746.

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