Warmed versus room-temperature contrast during hysterosalpingogram to reduce cramping and false tubal blockage

The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study: A Randomized Controlled Trial

This trial will test whether warming the contrast dye used during HSG reduces pain and the chance of a false proximal tubal blockage for women 18–45 having tubal testing for infertility.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: University of Oklahoma (Academic / other)
• Locations: 1 site (Oklahoma City, Oklahoma)
• Trial ID: NCT07226310 on ClinicalTrials.gov

What this trial studies

This single-center randomized study will assign women undergoing HSG to receive either warmed (body temperature) or room-temperature contrast in a 1:1 ratio using block randomization. Researchers will record patient demographics, medical and gynecologic history, HSG images and reports, and patient pain/cramping scores, with data stored in Epic and a PHI-safe REDCap database; no biospecimens will be collected. The HSG is typically scheduled in cycle days 5–10, and outcomes of interest include reported pain/cramping and rates of proximal tubal occlusion on imaging. Patients with prior tubal disease, certain pelvic conditions, prior pelvic surgery, or allergy to iodine-based contrast are excluded.

Who should consider this trial

Good fit: Women aged 18–45 undergoing HSG for tubal patency as part of infertility evaluation who do not have fibroids, PID, prior tubal or pelvic surgery, endometriosis, known Mullerian anomalies, prior abnormal HSG, hydrosalpinx, or iodine allergy are ideal candidates.

Not a fit: Patients with true structural tubal disease, prior abnormal HSG or hydrosalpinx, significant pelvic pathology, or iodine contrast allergy are unlikely to benefit from warmed contrast in terms of preventing true tubal obstruction.

Why it matters

Potential benefit: If successful, warmed contrast could reduce discomfort during HSG and lower the rate of iatrogenic proximal tubal occlusion, improving diagnostic accuracy and patient experience.

How similar studies have performed: Previous studies have shown warmed contrast reduces pain and uterine cramping during HSG, but its effect on reducing false proximal tubal occlusion has not been firmly established.

Eligibility criteria

Inclusion Criteria:

1\. Women ages 18-45 undergoing tubal assessment via HSG.

Exclusion Criteria:

1. History of fibroids
2. History of pelvic inflammatory disease (PID or STD including gonorrhea, chlamydia, or trichomonas)
3. History of surgically diagnosed endometriosis or suspected endometriosis on ultrasound (indicated by visualization of likely endometrioma)
4. History of ectopic pregnancy or 3 or more biochemical pregnancies/pregnancy of unknown location
5. History of tubal or ovarian surgery
6. History of known Mullerian anomaly
7. History of pelvic surgery including appendectomy
8. Allergy to iodine-based contrast media
9. History of prior abnormal fallopian tubes on HSG
10. History of ultrasound with hydrosalpinx (unilateral or bilateral)

Where this trial is running

Oklahoma City, Oklahoma

• University of Oklahoma Health Center — Oklahoma City, Oklahoma, United States (Recruiting)

Study contacts

• Principal investigator: LaTasha Craig, MD — University of Oklahoma Health Center
• Study coordinator: Christy Zornes, MHR

Conditions Infertility