NCT06988774 · Medstar Health Research Institute
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
(ATOM)
What this study 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.
View original scientific 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.
Interventions
PROCEDURE
chromopertubation
Pre- and post-myomectomy chromopertubation procedure using dilute methylene blue dye solution for evaluation of tubal occlusion
Primary outcome measures
Frequency of tubal occlusion pre- and post-myomectomy
Time frame: Limited to the duration of each surgery
Frequency of tubal occlusion in patients with fibroids immediately prior to and after completion of myomectomy procedures. Spillage of methylene blue dye seen laparoscopically is indicative of tubal patency. Unilateral vs bilateral occlusion will be documented.
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
- 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.
Exclusion criteria
- Patients with both fallopian tubes absent
- Patients in whom it is not possible to place a uterine manipulator or catheter
- Patient with known tubal disease or occlusion, or patients who have undergone prior tubal surgery
- Patients with allergy to methylene blue dye or G6PD deficiency
- Patients with positive pregnancy test on day of surgery
Where
- Washington D.C., District of Columbia
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Jun 29, 2025 · Source of record for eligibility and locations