Status:
RECRUITING
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Fallopian Tube Patency Tests
Fibroid/Myoma (Uterus/Cervix)
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 p...
Detailed Description
Background: Fibroids have a prevalence \>75%, making it the most common benign uterine disease \[Zepiridis 2016, Lazaridis 2013, Giuliani 2020\]. Fibroids are well known to contribute to infertility ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06988774
Start Date
June 2 2025
End Date
April 30 2026
Last Update
June 29 2025
Active Locations (1)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20001