Clinical trial · Interventional
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Disease | — | UNRESOLVED | — |
| Fallopian Tube Patency Tests | — | UNRESOLVED | — |
| Fibroid/Myoma (Uterus/Cervix) | — | UNRESOLVED | — |
| Myomectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chromopertubation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATOM study participants
- description
- Patients enrolled in the study who will undergo the chromopertubation per protocol
- interventionNames
- Procedure: chromopertubation
Primary outcomes (1)
- measure
- Frequency of tubal occlusion pre- and post-myomectomy
- timeFrame
- Limited to the duration of each surgery
- description
- Frequency of tubal occlusion in patients with fibroids immediately prior to and after completion of myomectomy procedures. Spillage of methylene blue dye seen laparoscopically is indicative of tubal patency. Unilateral vs bilateral occlusion will be documented.
Secondary outcomes (2)
- measure
- Frequency of tubal occlusion compared to fibroid characteristics
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (25)
- BACKGROUNDBarbieri RL. Farewell to indigo carmine. OBG Management. 2014. https://mdedge.com/obgmanagement/article/86698/pelvic-floor-dysfunction/farewell-indigo-carmine.
- BACKGROUNDZepiridis LI, Grimbizis GF, Tarlatzis BC. Infertility and uterine fibroids. Best Pract Res Clin Obstet Gynaecol. 2016 Jul;34:66-73. doi: 10.1016/j.bpobgyn.2015.12.001. Epub 2015 Dec 23. PMID 26856931
- BACKGROUNDSomigliana E, Reschini M, Bonanni V, Busnelli A, Li Piani L, Vercellini P. Fibroids and natural fertility: a systematic review and meta-analysis. Reprod Biomed Online. 2021 Jul;43(1):100-110. doi: 10.1016/j.rbmo.2021.03.013. Epub 2021 Mar 23. PMID 33903032
- BACKGROUNDSaunders RD, Shwayder JM, Nakajima ST. Current methods of tubal patency assessment. Fertil Steril. 2011 Jun;95(7):2171-9. doi: 10.1016/j.fertnstert.2011.02.054. Epub 2011 Mar 31. PMID 21457959
- BACKGROUNDSankey-Thomas KM, Travieso J, Salazar CA, Williams-Brown M, Breen MT. Fertility sparing management of a large broad ligament fibroid. Journal of Minimally Invasive Gynecology. 2024;31(11, Supplement):S6.
- BACKGROUNDRzymski P, Wozniak J, Opala T, Wilczak M, Sajdak S. Anaphylactic reaction to methylene blue dye after laparoscopic chromopertubation. Int J Gynaecol Obstet. 2003 Apr;81(1):71-2. doi: 10.1016/s0020-7292(03)00036-5. No abstract available. PMID 12676403
- BACKGROUNDRamin S, Azar FP, Malihe H. Methylene blue as the safest blue dye for sentinel node mapping: emphasis on anaphylaxis reaction. Acta Oncol. 2011 Jun;50(5):729-31. doi: 10.3109/0284186X.2011.562918. Epub 2011 Mar 17. No abstract available. PMID 21413854
- BACKGROUNDPritts EA, Parker WH, Olive DL. Fibroids and infertility: an updated systematic review of the evidence. Fertil Steril. 2009 Apr;91(4):1215-23. doi: 10.1016/j.fertnstert.2008.01.051. Epub 2008 Mar 12.