Does minimally invasive fibroid removal change whether fallopian tubes are open?
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
This study will test if fallopian tubes are open before and after minimally invasive fibroid removal in people having myomectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06988774 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study uses chromopertubation during laparoscopic or robotic uterine-preserving myomectomy to document tubal patency before and after fibroid removal. A dilute methylene blue solution is introduced into the uterus during surgery to see whether dye spills from the fallopian tubes, with the minimum dye dose used to reduce risk. Patients with prior tubal surgery, known tubal occlusion, absent tubes, pregnancy, methylene blue allergy, or G6PD deficiency are excluded. The goal is to clarify whether fibroids or their surgical removal affect tubal openness and thus could influence fertility counseling and management.
Who should consider this trial
Good fit: People scheduled for minimally invasive uterine-preserving myomectomy at MedStar who have at least one fallopian tube, can have a uterine manipulator placed, are not pregnant, and have no methylene blue allergy or G6PD deficiency.
Not a fit: Patients with absent tubes, known tubal disease or prior tubal surgery, allergy to methylene blue or G6PD deficiency, inability to place a uterine manipulator, or those not undergoing myomectomy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help doctors know whether removing fibroids restores or preserves tubal openness and may improve guidance on chances for natural pregnancy.
How similar studies have performed: Chromopertubation itself is an established technique for checking tubes, but there are very few prospective studies specifically measuring tubal patency before and after myomectomy, so this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Washington D.C., District of Columbia
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Study coordinator: Alexandra Snyder, MD
- Email: alexandra.snyder@medstar.net
- Phone: 202-877-6526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.