Transvaginal Ablation for Polycystic Ovary Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Will I have to stop taking my current medications?
You will need to stop taking any first-line ovulation induction treatments like clomiphene citrate, letrozole, or metformin (unless metformin is needed for blood sugar control) until the 3-month endpoint of the study is reached.
How is the transvaginal ablation treatment for PCOS different from other treatments?
Transvaginal ablation for PCOS is unique because it involves a minimally invasive surgical approach, unlike the more common medical treatments such as oral contraceptives or insulin-sensitizing drugs. This method may be considered for women who are resistant to drug therapy and aims to improve ovulation and pregnancy rates.12345
What data supports the effectiveness of the treatment for polycystic ovary syndrome?
Who Is on the Research Team?
Karl Hansen, MD
Principal Investigator
Oklahoma University Health Sciences Center
Anuja Dokras, MD, PhD
Principal Investigator
Penn Fertility Care
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo transvaginal ablation of ovarian tissue under ultrasound guidance
Follow-up
Participants are monitored for ovulation occurrence and hormone levels
Crossover
Participants in the control arm may choose to crossover to the device arm after the 3-month follow-up visit
What Are the Treatments Tested in This Trial?
Interventions
- May Health System
Find a Clinic Near You
Who Is Running the Clinical Trial?
May Health
Lead Sponsor