Actively Recruiting
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Led by Weill Medical College of Cornell University · Updated on 2026-03-13
40
Participants Needed
3
Research Sites
94 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
S
Society of Interventional Radiology Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to see if a randomized controlled trial of ovarian vein and pelvic vein embolization versus venography alone could determine outcomes for women with chronic pelvic pain and pelvic varicose veins. The data gathered will assist in addressing changes in quality of life in patients who have ovarian/pelvic vein embolization versus no embolization.
CONDITIONS
Official Title
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age 18 to 75 years, pre-menopausal
- Chronic pelvic pain lasting more than 6 months with a pain score of 7 or higher based on 4 weeks of self-assessments
- Pain worsened by walking, standing, or lifting and partially relieved by lying down
- Prolonged ache after sexual intercourse
- No non-venous causes of chronic pelvic pain as confirmed by gynecological exam
- Imaging showing ovarian vein diameter of 6 mm or greater
- Presence of pelvic varices with at least one vein larger than 5 mm in diameter
- Venous reflux in ovarian and/or internal iliac veins without significant vein narrowing
- Symptoms and imaging findings consistent with Pelvic Venous Disease
You will not qualify if you...
- Female younger than 18 years
- Pregnant or planning pregnancy during the study
- Currently breastfeeding
- Post-menopausal or anovulatory with hormone suppression
- History of hysterectomy
- Prior ovarian vein embolization or ligation
- Unable to tolerate endovascular procedures due to acute illness or poor general health
- Planned nerve block treatments or surgeries during the study period
- Allergies to sclerosants, coils, stents, catheters, or nickel
- Significant iliac or renal vein stenosis as determined by imaging and expert review
- Presence of isolated external vulvar or lower extremity varices without pelvic varices
- Serious medical conditions that prevent full participation (e.g., uncontrolled diabetes, cancer, heart or lung disease)
- Severe allergy to iodinated or gadolinium contrast not responsive to steroids
- Severe kidney impairment or dialysis
- Low hemoglobin, high INR, or low platelet count
- Unable to provide informed consent or comply with study procedures
- Post-thrombotic changes in inferior vena cava, iliac, or ovarian veins
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Weill Cornell Medicine
New York, New York, United States, 10024
Actively Recruiting
2
UNC School of Medicine
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
3
Lake Washington Vascular
Bellevue, Washington, United States, 98004
Withdrawn
Research Team
R
Ronald S Winokur, MD
CONTACT
S
Sasha Garcia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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