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Study of Ovarian and Pelvic Vein Embolization for Chronic Pelvic Pain

This study is looking at whether a procedure called ovarian vein and pelvic vein embolization can help women aged 18 to 75 who have chronic pelvic pain (pain lasting more than 6 months) and enlarged veins in their pelvis, called pelvic varices. The procedure involves blocking these veins. Researchers want to see if this treatment improves pain and quality of life compared to just having a diagnostic test called venography (an X-ray of the veins). To join, your pain must be severe (VAS ≥7) and not improved by other treatments. The main goal is to measure changes in your pelvic pain using a pain scale over 6 months. The current status of this study is unclear.

Study design
This is a randomized study with 40 participants. You would be randomly assigned to either receive the embolization procedure or venography only.
What's involved
You would have weekly pain assessments for 4 weeks before the procedure, and then follow-up assessments at 30, 90, and 180 days after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the procedure to assess changes in pain and quality of life.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06168058

Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices

Recruiting
NAAges 18–75InterventionalTreatment
Weill Medical College of Cornell University
~40 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Transcatheter VenographyBilateral ovarian vein embolization

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Visual Analog Scale (VAS) for pelvic pain
Measured over Weekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up

Conditions

Chronic Pelvic Pain Syndrome
Pelvic Pain
Pelvic Varices
Pelvic Congestive Syndrome
Pelvic Pain Syndrome

Explore related trials

Pelvic congestion syndromePelvic PainVaricose veins of pelvis

Where it's being run

4 sites across 3 states
New York2
North Carolina1
Washington1

Study leadership

  • Neil M Khilnani, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Neil M Khilnani, MD
[email protected]
646-962-9179
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pain exacerbated by walking, standing or lifting
Symptoms are at least partially alleviated by lying down
Prolonged post-coital ache
Absence of non-venous origin CPP as determined by Gynecology examination 2. Symptoms-Varices-Pathophysiology Classification18 including of one of the following:
Left or right ovarian vein diameter greater than or equal to 6 mm as documented by TAUS or CT
Presence of intrabdominal/pelvic varices as documented by TAUS or CT (≥1 veins, \>5 mm diameter)
Presence of venous reflux in ovarian and/or internal iliac veins without evidence of hemodynamically significant stenosis

Exclusion

Female \<18 years of age
Pregnancy (positive pregnancy test)
Female subject who plans to become pregnant during study period
Female subject who is actively breastfeeding
Patient who is post-menopausal or anovulatory with hormone suppression
History of prior hysterectomy
Prior ovarian vein embolization or ovarian vein ligation
Inability to tolerate endovascular procedure due to acute illness or general health
Planned simultaneous treatment with nerve blocks during the duration of the study
Laparoscopy or planned surgical intervention during the duration of the study
Known allergy to sclerosant, coil, stent or catheter components including nickel allergy
Any iliac vein stenosis determined identified by the investigator on pelvic DUS, CT venogram, and/or Catheter Venography and deemed significant for exclusion by study patient review committee.
Any renal vein stenosis with resultant renal hilar varices/collaterals and lumbar collaterals identified by the investigator on pelvic DUS, CT venogram, and/or Diagnostic Venography and deemed significant for exclusion by study patient review committee.
Presence of isolated extra-pelvic vulvar and/or lower extremity varices without intrabdominal pelvic varices. Primary S3 categorization study exclusion.
Serious medical conditions that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, COPD, MI, CHF, etc.)
Severe allergy to iodinated or gadolinium-based contrast refractory to steroid premedication
Severe renal impairment (on chronic dialysis or estimated GFR \<30 mL/min)
Hemoglobin \<8.0 g/dL, uncorrectable INR \>3.0 or platelet count \<75,000/microliter
Inability to provide informed consent or to comply with study assessments
Post thrombotic IVC, iliac or ovarian vein changes

What this trial measures

  • Change in Visual Analog Scale (VAS) for pelvic painWeekly for 4 weeks prior to Day 1 and at 30, 90 and 180 day follow up

    The VAS pain score is a standard scale from 0 to 10, defining 0 as ''no pain'' and 10 ''worst pain possible.''