NCT06988774 Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
| NCT ID | NCT06988774 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medstar Health Research Institute |
| Condition | Fallopian Tube Patency Tests |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-06-02 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06988774 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fallopian Tube Patency Tests. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06988774 currently recruiting?
Yes, NCT06988774 is actively recruiting participants. Contact the research team at alexandra.snyder@medstar.net for enrollment information.
Where is the NCT06988774 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06988774 clinical trial?
NCT06988774 is sponsored by Medstar Health Research Institute. The trial plans to enroll 50 participants.