Chromopertubation for Uterine Fibroids
(ATOM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for patients scheduled for minimally invasive surgery to remove uterine fibroids at MedStar. It's specifically looking at how these fibroids and their removal affect the fallopian tubes, which are important for natural pregnancy.Inclusion Criteria
Timeline for a Trial Participant
Pre-surgery Chromopertubation
Chromopertubation is performed at the start of the laparoscopic or robotic surgical procedure to assess tubal patency before myomectomy.
Surgical Intervention
Surgical removal of fibroids (myomectomy) is performed.
Post-surgery Chromopertubation
Chromopertubation is performed again at the end of the surgery to assess changes in tubal patency after myomectomy.
Post-operative Monitoring
Patients are monitored for adverse events in the post-anesthesia care unit (PACU) and receive a follow-up call on post-operative day #1.
What Are the Treatments Tested in This Trial?
Interventions
- Chromopertubation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medstar Health Research Institute
Lead Sponsor