Actively Recruiting
Randomized Controlled, Single-Blinded Trial of Ovarian Vein and Pelvic Vein Embolization Versus Venography Alone 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
N/A
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
This trial investigates women with chronic pelvic pain and pelvic varicose veins, focusing on how ovarian vein and pelvic vein embolization compares to venography alone. It aims to understand changes in pain and quality of life for women who have dilated and incompetent ovarian veins and pelvic varices. The study is a randomized controlled trial designed to gather data on outcomes for these patients. Participants will be randomly assigned to one of two groups: one receiving bilateral ovarian vein embolization and pelvic vein embolization, and the other undergoing venography only. The embolization procedure involves sclerosis of pelvic varices and coil embolization of the ovarian veins. The study includes a single-blinded, parallel-group design, with follow-up assessments after the procedure. Women aged 18 to 75 who are pre-menopausal and meet specific clinical and imaging criteria related to pelvic venous disease will be involved. Pain levels will be regularly assessed using the Visual Analog Scale (VAS) and other quality of life tools like PROMIS scales, Patient Global Impression of Change, and the EuroQol five-dimension scale. Follow-up will occur weekly for four weeks prior to treatment and then at 1, 3, and 6 months after the procedure to monitor changes in pain and quality of life.
CONDITIONS
Brief 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 aged 18 to 75 years
- Pre-menopausal women with chronic pelvic pain lasting more than 6 months
- Pain score of 7 or higher on Visual Analog Scale during 4 consecutive weeks before enrollment
- Pain worsened by walking, standing, or lifting and partially relieved by lying down
- Prolonged ache after sexual intercourse
- No non-venous origin chronic pelvic pain as confirmed by gynecological exam
- Imaging showing ovarian vein diameter ≥6 mm and pelvic varices (≥1 vein >5 mm diameter)
- Presence of venous reflux in ovarian or internal iliac veins without significant stenosis
- Willingness to comply with study procedures and assessments
You will not qualify if you...
- Female under 18 years of age
- Pregnancy or positive pregnancy test
- Actively breastfeeding
- Planning to become pregnant during study period
- Post-menopausal or anovulatory with hormone suppression
- History of prior hysterectomy
- Prior ovarian vein embolization or ligation
- Unable to tolerate endovascular procedure due to acute illness or general health
- Planned simultaneous nerve block treatment during study
- Planned laparoscopy or surgical intervention during study
- Allergy to sclerosant, coil, stent, catheter components, or nickel
- Significant iliac or renal vein stenosis as determined by imaging and review committee
- Isolated extra-pelvic vulvar or lower extremity varices without intra-abdominal varices
- Serious medical conditions preventing full study participation (e.g., uncontrolled diabetes, malignancy, COPD, MI, CHF)
- Severe allergy to iodinated or gadolinium contrast not manageable by steroids
- Severe renal impairment (dialysis or estimated GFR <30 mL/min)
- Low hemoglobin (<8.0 g/dL), uncorrectable clotting issues, or low platelets (<75,000/microliter)
- Unable to provide informed consent or comply with assessments
- Post thrombotic changes in IVC, iliac, or ovarian veins
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Weekly visits for up to 4 weeks
Duration - Single day procedure
Participants undergo either bilateral ovarian vein and pelvic vein embolization or venography alone as part of the treatment.
1 procedure visit (in-person)
Duration - 6 months
Participants are monitored for changes in pelvic pain and quality of life after the procedure.
Weekly visits for 4 weeks, then visits at 1, 3, and 6 months post procedure
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
S
Sasha Garcia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here