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Assessment of Tubal Occlusion During Minimally Invasive Myomectomy

Study acronym: ATOM
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 29, 2025 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 22, 2025 to Jun 2, 2025
    • Study description expanded, about 2 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06988774
Lead Sponsor Medstar Health Research Institute
Conditions
(from sponsor)
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix), Myomectomy, Fallopian Tube Disease
Related terms Fallopian Tube Diseases, Leiomyoma, Myoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov