The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study
Part of paid clinical trials in Oklahoma City, Oklahoma.
- Sponsor
- University of Oklahoma
- Study ID
- NCT07226310
- Phase
- EARLY_PHASE1
- Status
- Recruiting
Conditions
- Infertility
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Not accepted
Interventions
- Warmed HSG — DRUGThe intervention is warming the HSG constrast.
Study Details
The hysterosalpingogram (HSG) is the gold standard of assessing fallopian tube patency and involves the placement of a transcervical catheter to allow for instillation of radio-opaque dye into the uterine cavity and fallopian tubes which are then imaged with abdominal x-ray. A common side effect of the instillation of dye is the uterine cramping, which is both uncomfortable for the patient as well as can cause iatrogenic proximal occlusion of the fallopian tubes. Proximal tubal obstruction is often not representative of true tubal obstruction but is rather an artifact of the test. Prior studies measuring the perceived pain and cramping during HSG have been conducted which have shown reduced pain scores and decreased uterine cramping when warmed contrast dye is used. The researchers propose that the use of warmed contrast media during HSG will be correlated with decreased pain scores and fewer cases of proximal tubal occlusion in women with otherwise normal uterine anatomy.
Key Dates
- Start date
- May 31, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- No Intervention: Cold HSGHSG contrast will be standard, room-temperature
- Active Comparator: Warm HSGHSG constrast will be warmed.
Primary Outcome Measure
Post-HSG Pain Questionnaire [ Time Frame: Measured 1 hour after HSG procedure ]
Central Contacts
- Christy Zornes, MHR(405) 271-8001
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Oklahoma Health Center | Oklahoma City | Oklahoma | 73104 | LaTasha Craig, MD (PRINCIPAL_INVESTIGATOR) |
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