Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06988774

Assessment of Tubal Occlusion During Minimally Invasive Myomectomy

Led by Medstar Health Research Institute · Updated on 2025-06-29

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of uterine fibroids and fibroid surgery on the openness of fallopian tubes in women undergoing minimally invasive surgery. The study aims to understand if fibroids cause blockage of the fallopian tubes and how surgery to remove fibroids (myomectomy) affects this condition. This is important because open fallopian tubes are necessary for natural pregnancy, and current knowledge about how fibroids influence tubal function is limited. The study involves a procedure called chromopertubation, performed twice during planned laparoscopic or robotic myomectomy surgery. This procedure uses a dilute methylene blue dye injected into the uterus to see if the dye passes through the fallopian tubes, indicating whether they are open or blocked. Chromopertubation is done at the start and end of the surgery, taking less than 10 minutes in total. Researchers will record tubal patency and fibroid characteristics such as size, number, and location. Participants will be monitored for any adverse reactions during and after the surgery according to standard care. Data collected include tubal openness before and after surgery, fibroid details, and patient medical history. Follow-up includes a post-operative call to check on recovery. The primary outcome measured is the frequency of tubal occlusion before and after myomectomy, with no long-term follow-up planned. The total study participation coincides with the surgery and immediate recovery period.

CONDITIONS

Brief Title

Assessment of Tubal Occlusion During Minimally Invasive Myomectomy

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing minimally invasive laparoscopic or robotic-assisted uterine-preserving surgery to remove uterine fibroids by a minimally invasive gynecologic surgeon at MedStar
Not Eligible

You will not qualify if you...

  • Patients with both fallopian tubes absent
  • Patients in whom it is not possible to place a uterine manipulator or catheter
  • Patients with known tubal disease or occlusion, or prior tubal surgery
  • Patients allergic to methylene blue dye or with G6PD deficiency
  • Patients with a positive pregnancy test on the day of surgery
  • Patients unable to undergo chromopertubation procedure due to surgical limitations or safety concerns
  • Patients who do not meet safety criteria for the procedure as determined by the surgical team (implied by standard monitoring and procedural abort criteria but not explicitly listed in eligibility criteria)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment prior to surgery

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo minimally invasive myomectomy surgery with chromopertubation performed before and after the surgical procedure to assess tubal occlusion.

1 surgical visit including pre- and post-myomectomy chromopertubation procedures

Post-operative Follow-up

Duration - 1 to 2 days

Participants are observed in the post-anesthesia care unit and contacted on post-operative day 1 to monitor for any adverse events following the surgery and chromopertubation procedures.

1 post-operative phone call or in-person assessment on Day 1 after surgery

Trial Site Locations

Total: 1 location

1

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20001

Actively Recruiting

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Research Team

A

Alexandra Snyder, MD

M

Mireille Truong, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

A Large Study About Reproductive Factors That Predict Hysterosalpingography-Identified Tubal Pathology: An Insight into the Necessity of Preconception Screening.

Yurie Nako, Kuniaki Ota, Toshio Sujino...

https://pubmed.ncbi.nlm.nih.gov/39797266

Are the Stage and the Incidental Finding of Endometriosis Associated with Fallopian Tube Occlusion? A Retrospective Cohort Study on Laparoscopic Chromopertubation in Infertile Women.

Daniel Mayrhofer, John Preston Parry, Marlene Hager...

https://pubmed.ncbi.nlm.nih.gov/35807038