Warmed versus room-temperature contrast during hysterosalpingogram to reduce cramping and false tubal blockage
Official title: The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study: A Randomized Controlled Trial
Run by University of Oklahoma · NCT07226310 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07226310 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: christy-zornes@ou.edu
- Phone: (405) 271-8001
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI-assisted embryo selection on day 5 in IVF for infertility
This trial tests whether an AI-based embryo selection tool can help pick the best embryo for transfer on day 5 in IVF/ICSI to improve pregnancy chances for people with infertility.
-
Preserving sperm quality with aging through cryopreservation
This study tests whether freezing and thawing sperm can help keep younger-like DNA and molecular traits in men as they age.
-
Unstimulated Egg Retrieval with CAPA-IVM and Euploid Embryo Transfer
This study tests whether eggs can be collected without ovarian stimulation, matured in the lab, and used to create a single euploid embryo for transfer in infertility patients.
-
Ultra-Long GnRH-a Pretreatment Before Frozen Embryo Transfer for Deep Infiltrating Endometriosis
In people under 40 with deep infiltrating endometriosis and infertility, the study tests whether two injections of a GnRH agonist before hormone support improve pregnancy outcomes in their first frozen-thawed embryo transfer.
-
Endometrial Waves and Pregnancy in FET Cycles with Hormone Therapy
This study tests whether patterns of uterine contractions during hormone-prepared frozen embryo transfer affect pregnancy outcomes.
-
Environmental and lifestyle factors linked to ART success in infertility patients
This study follows 5,000 infertile men and women to see how environmental exposures and lifestyle relate to the success of assisted reproductive technology.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.