RecruitingNot ApplicableNCT06988774

Assessment of Tubal Occlusion During Minimally Invasive Myomectomy


Sponsor

Medstar Health Research Institute

Enrollment

50 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at ways to assess whether the fallopian tubes remain open (unblocked) after minimally invasive surgery to remove uterine fibroids (a procedure called myomectomy). Understanding this can help preserve fertility for patients who want to become pregnant in the future. **You may be eligible if...** - You are a woman undergoing laparoscopic or robotic-assisted surgery to remove uterine fibroids at MedStar **You may NOT be eligible if...** - Both of your fallopian tubes are absent - A uterine manipulator or catheter cannot be placed - You have known fallopian tube disease, blockage, or prior tube surgery - You have an allergy to methylene blue dye or have G6PD deficiency (an enzyme deficiency) - You have a positive pregnancy test on the day of surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREchromopertubation

Pre- and post-myomectomy chromopertubation procedure using dilute methylene blue dye solution for evaluation of tubal occlusion


Locations(1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

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NCT06988774


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