Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Key facts
- Who runs it
- Medstar Health Research Institute
- Where
- Washington D.C., United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 50 people, planned
- Started
- 2 Jun 2025
- Planned end
- 30 Apr 2026
- Type of study
- Interventional
- Treatments tested
- chromopertubation
- Record updated
- 29 June 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patient with known tubal disease or occlusion, or patients who have undergone prior tubal surgery
- Patients with positive pregnancy test on day of surgery
- Patients with allergy to methylene blue dye or G6PD deficiency
- Patients with both fallopian tubes absent
- Patients in whom it is not possible to place a uterine manipulator or catheter
Where in United States
- MedStar Washington Hospital CenterWashington D.C., United StatesContact: Alexandra Snyder, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- ATOM study participantsTreatment being tested
Patients enrolled in the study who will undergo the chromopertubation per protocol
Treatment: chromopertubation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 29 June 2025