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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

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 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

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.

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
~105 spots leftby May 2025
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