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Procedure

Transvaginal Ablation 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

Must not have

Active genital or urinary tract infection at the time of the procedure

Bleeding disorders, such as von Willebrand disease, thrombocytopenia, current use of anticoagulation medication, etc.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month visit through 36 month visit

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active genital or urinary tract infection.

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I have a bleeding disorder or am on blood thinners.

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I have or might have scar tissue around my ovaries.

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I have undergone more than 2 treatment cycles with hormone therapy.

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I have had surgery on my ovaries or fallopian tubes before.

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A transvaginal ultrasound cannot get close to at least one of my ovaries.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse event collection

Ovulation occurrence

Secondary study objectives

Cumulative ovulation rate at 6 months with 1st-line

Cumulative ovulation rate at 6 months without 1st-line

Documented pregnancy

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met