RECRUITING

Assessment of Tubal Occlusion During Minimally Invasive Myomectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessment of Tubal Occlusion During Minimally Invasive Myomectomy

Quick Facts

Study Start:2025-06-02
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06988774

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing minimally invasive laparoscopic or robotic-assisted uterine-preserving gynecologic surgery for removal of uterine fibroids (myomectomy) by a minimally invasive gynecologic surgeon at MedStar.
  1. * Patients with both fallopian tubes absent
  2. * Patients in whom it is not possible to place a uterine manipulator or catheter
  3. * Patient with known tubal disease or occlusion, or patients who have undergone prior tubal surgery
  4. * Patients with allergy to methylene blue dye or G6PD deficiency
  5. * Patients with positive pregnancy test on day of surgery

Contacts and Locations

Study Contact

Alexandra Snyder, MD
CONTACT
202-877-6526
alexandra.snyder@medstar.net
Mireille Truong, MD
CONTACT
202-877-6526
mireille.d.truong@medstar.net

Study Locations (Sites)

MedStar Washington Hospital Center
Washington, District of Columbia, 20001
United States

Collaborators and Investigators

Sponsor: Medstar Health Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-02
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2025-06-02
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • chromopertubation
  • myomectomy
  • uterine fibroids
  • fallopian tube disease

Additional Relevant MeSH Terms

  • Fallopian Tube Patency Tests
  • Fibroid/Myoma (Uterus/Cervix)
  • Myomectomy
  • Fallopian Tube Disease