Recruiting
Early Phase 1

Warmed Contrast Dye

Sponsor:

University of Oklahoma

Code:

NCT07226310

Conditions

Infertility

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Warmed HSG

Study Details

Brief summary:

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.

Conditions

Infertility

Study ID

NCT07226310

Start date

Sep, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Cold HSG

HSG contrast will be standard, room-temperature

active comparator: Warm HSG

HSG constrast will be warmed.

Interventions

Warmed HSG

The intervention is warming the HSG constrast.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Christy Zornes, MHR

(405) 271-8001christy-zornes@ou.edu

Locations

University of Oklahoma Health Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Christy Zornes, MHR

405-271-8001christy-zornes@ou.edu

Principal Investigator:

LaTasha Craig, MD

More Information

Sponsor

University of Oklahoma

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-07-30.