Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06988774

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

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study uses a procedure called chromopertubation to look at how fibroids and fibroid surgery affect the fallopian tubes. Specifically, this study will test if the fallopian tubes are occluded or patent (open) before and after surgically removing fibroids. Chromopertubation is a commonly performed and well-established procedure that is done during laparoscopic surgery to determine if the fallopian tubes are open or blocked. It includes inserting a dilute solution of saline with a small amount of medical-grade blue dye (called methylene blue) into the uterine cavity to see if it spills out of the fallopian tubes. Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare. The minimum amount of methylene blue dye will be used to further reduce risks of a reaction. Open fallopian tubes are necessary to become pregnant without the use of IVF. While it is known that some conditions can affect the functioning of the fallopian tubes, there is a lack of research about how fibroids affect the tubes. It is also not known how much about how the process of removing fibroids may affect the fallopian tubes. The investigators hypothesize that tubal occlusion will be observed in patients with fibroids and that the frequency of tubal occlusion will change after myomectomy compared to pre-myomectomy. This study will be conducted entirely during planned surgery for laparoscopic myomectomy. Chromopertubation will be performed at the beginning and again at the end of the surgery. This is expected to take less than 10 minutes in total. The results of the chromopertubation as well as background medical information will be recorded and the characteristics of the fibroids (size, number, and location) will be compared to the presence or abscence of tubal occlusion as determined by chromopertubation.

CONDITIONS

Official 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 specialized gynecologic surgeon at MedStar
Not Eligible

You will not qualify if you...

  • Patients with both fallopian tubes absent
  • Patients in whom uterine manipulator or catheter placement is not possible
  • Patients with known tubal disease, 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

AI-Screening

AI-Powered Screening

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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

CONTACT

M

Mireille Truong, MD

CONTACT

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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