Chromopertubation for Uterine Fibroids

(ATOM Trial)

Recruiting at 1 trial location

Overseen By Mireille Truong, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Disqualifiers: Tubal disease, Allergy to dye, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how uterine fibroids and their surgical removal affect the openness of the fallopian tubes, which are essential for natural conception. The trial employs a safe and simple procedure called chromopertubation, where a blue dye solution checks if the tubes are open or blocked during surgery. Women planning to have fibroids surgically removed and with no known tubal issues might be suitable candidates for this trial. The goal is to determine if fibroids or the surgery itself impacts the fallopian tubes. Participants will undergo the procedure during their scheduled fibroid surgery, with minimal added time. As an unphased trial, this study offers a unique opportunity to contribute to understanding how fibroid surgery might affect fertility.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that chromopertubation is safe for examining uterine fibroids?

Research has shown that chromopertubation is a safe and well-known procedure. It checks whether the fallopian tubes are open or blocked by using a small amount of medical-grade blue dye. The main risk is an allergic reaction to the dye, though this is very rare. To minimize this risk, only the smallest necessary amount of dye is used. Overall, chromopertubation is considered safe, with very few negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about chromopertubation for uterine fibroids because it offers a new approach to understanding and potentially treating this condition. Unlike traditional treatments like medication to regulate hormones or surgical options such as myomectomy and hysterectomy, chromopertubation involves a diagnostic technique that uses a dye to assess the patency of the fallopian tubes. This method could provide clearer insights into how uterine fibroids affect fertility and help tailor more precise treatment plans. By enhancing our comprehension of fibroid-related complications, this trial aims to improve outcomes for women facing this common health issue.

What evidence suggests that chromopertubation is effective for assessing fallopian tube patency in patients with uterine fibroids?

Studies have shown that chromopertubation reliably checks if fallopian tubes are open or blocked. For individuals with fibroids, it helps assess how these growths might affect the tubes. Research suggests that removing fibroids can improve fertility, possibly by keeping the tubes open. In one study, chromopertubation revealed that 61.1% of fallopian tubes were open, demonstrating its usefulness. Participants in this trial will undergo chromopertubation to assess its impact on fertility outcomes for those with uterine fibroids. Patients who underwent similar procedures in other studies experienced better fertility outcomes. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients scheduled for minimally invasive surgery to remove uterine fibroids at MedStar. It's specifically looking at how these fibroids and their removal affect the fallopian tubes, which are important for natural pregnancy.

Inclusion Criteria

I am having a surgery to remove fibroids without removing my uterus, using a robot or small incisions.

Timeline for a Trial Participant

Pre-surgery Chromopertubation

Chromopertubation is performed at the start of the laparoscopic or robotic surgical procedure to assess tubal patency before myomectomy.

Less than 10 minutes

1 visit (in-person, during surgery)

Surgical Intervention

Surgical removal of fibroids (myomectomy) is performed.

Duration of surgery

1 visit (in-person, during surgery)

Post-surgery Chromopertubation

Chromopertubation is performed again at the end of the surgery to assess changes in tubal patency after myomectomy.

Less than 10 minutes

1 visit (in-person, during surgery)

Post-operative Monitoring

Patients are monitored for adverse events in the post-anesthesia care unit (PACU) and receive a follow-up call on post-operative day #1.

1 day

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• Chromopertubation

Trial Overview The study tests if the fallopian tubes are open or blocked before and after fibroid removal using chromopertubation. This involves a blue dye test during laparoscopic myomectomy to assess tubal patency.

How Is the Trial Designed?

Group I: ATOM study participants Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06988774

Assessment of Tubal Occlusion During Minimally Invasive ... This study uses a procedure called chromopertubation to look at how fibroids and fibroid surgery affect the fallopian tubes. Specifically, this study will ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6193424/

Robot-assisted laparoscopic myomectomy: current status Chromopertubation using the uterine manipulator will also allow for ... uterine fibroids: 10-year outcomes from the randomized EMMY trial. Am J ...

3. ijrcog.org ijrcog.org/index.php/ijrcog/article/download/15186/9453/64049

Clinical usefulness of hysterolaparoscopy and ... Patients undergoing interventions demonstrated significant improvements in fertility outcomes. However further research is warranted to explore ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155346501930127X

Assessment of Tubal Patency: A Prospective Comparison ... One-hundred forty-four fallopian tubes were evaluated, with 88 (61.1%) patent tubes at laparoscopic chromopertubation. A positive hysteroscopic flow effect was ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4999333/

Laparoscopic Chromopertubation, Myomectomy with Opening ... Fertility outcomes are decreased in women with submucosal fibroids, and removal of such fibroids seems to confer benefit. The effect of intramural fibroids ...

6. trialx.com trialx.com/clinical-trials/listings/299837/assessment-of-tubal-occlusion-during-minimally-invasive-myomectomy/

Assessment of Tubal Occlusion During Minimally Invasive ... Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare.

7. withpower.com withpower.com/trial/phase-fibroidmyoma-uteruscervix-4-2025-94b2f

Chromopertubation for Uterine Fibroids (ATOM Trial) Chromopertubation is considered a safe procedure - the main risk is an allergic reaction to the dye, which is very rare.