Assessment of Tubal Occlusion During Minimally Invasive Myomectomy

NCT06988774 | Recruiting

• 1 other identifier: STUDY00008836
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fallopian Tube Patency Tests; Fibroid/Myoma (Uterus/Cervix); Myomectomy; Fallopian Tube Disease

Keywords

chromopertubation; myomectomy; uterine fibroids; fallopian tube disease

Outcome Measures

Primary Outcomes (1)

• Frequency of tubal occlusion pre- and post-myomectomy

  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.

  Limited to the duration of each surgery

Secondary Outcomes (2)

• Frequency of tubal occlusion compared to fibroid characteristics

  Limited to the duration of each surgery

• Change in tubal occlusion

  Limited to the duration of each surgery

Study Arms (1)

ATOM study participants

EXPERIMENTAL

Patients enrolled in the study who will undergo the chromopertubation per protocol

Procedure: chromopertubation

Interventions

chromopertubation PROCEDURE

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

ATOM study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20001, United States

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Leiomyoma; Myoma; Fallopian Tube Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Alexandra Snyder, MD

CONTACT

202-877-6526; alexandra.snyder@medstar.net

Mireille Truong, MD

CONTACT

202-877-6526; mireille.d.truong@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: June 2, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)