NCT06168058 · Weill Medical College of Cornell University
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
(EMBOLIZE)
What this study is about
The purpose of this study is to see if a randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Presence of venous origin chronic pelvic pain for greater than 6 months (VAS ≥7 as determined by 4 consecutive weeks of baseline self-assessments) despite non-vascular therapy as delineated by the following criteria:
- 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
- Symptoms-Varices-Pathophysiology Classification18 including of one of the following: •S2V2PBGV,R,NT, S2V2PRGV,R,NT , S2V2PLGV,R,NT, with or without S2V2 PBIIV,R,NT, S2V2 PLIIV,R,NT, S2V2 PRIIV,R,NT
- CT, TAUS and diagnostic venography (if needed) imaging review for pelvic venous imaging factors
- 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 criteria
- 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
Where
- New York, New York
- Chapel Hill, North Carolina
- Bellevue, Washington
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations