Recruiting

Chromopertubation

Sponsor:

Medstar Health Research Institute

Code:

NCT06988774

Conditions

Fallopian Tube Patency Tests

Fibroid/Myoma (Uterus/Cervix)

Myomectomy

Fallopian Tube Disease

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

chromopertubation

Study Details

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

Study ID

NCT06988774

Start date

Jun 2, 2025

Status verified date

Jun, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: ATOM study participants

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

Interventions

chromopertubation

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

Primary outcome measure

  • Frequency of tubal occlusion pre- and post-myomectomy [ Time Frame: Limited to the duration of each surgery ]

Central Contacts and Locations

Locations

MedStar Washington Hospital Center

Recruiting

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

Contacts

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Jun 29, 2025

Last verified

Jun, 2025

Keywords

  • chromopertubation
  • myomectomy
  • uterine fibroids
  • fallopian tube disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2025-06-29.