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 — DRUG
    The 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 HSG
    HSG contrast will be standard, room-temperature
  • Active Comparator: Warm HSG
    HSG constrast will be warmed.

Primary Outcome Measure

Post-HSG Pain Questionnaire [ Time Frame: Measured 1 hour after HSG procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health CenterOklahoma CityOklahoma73104
Christy Zornes, MHR
405-271-8001
LaTasha Craig, MD (PRINCIPAL_INVESTIGATOR)

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