The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study

NCT07226310 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 18943
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Post-HSG Pain Questionnaire

  To compare the patient experience for patients undergoing HSG when warm versus cold contrast media is utilized, patients will complete a post-HSG Questionnaire to indicate their level of pain.

  Measured 1 hour after HSG procedure

Secondary Outcomes (1)

• Rate of unilateral and bilateral proximal fallopian tube occlusion

  Measured at the time of HSG procedure

Study Arms (2)

Cold HSG

NO INTERVENTION

HSG contrast will be standard, room-temperature

Warm HSG

ACTIVE COMPARATOR

HSG constrast will be warmed.

Drug: Warmed HSG

Interventions

Warmed HSG DRUG

The intervention is warming the HSG constrast.

Warm HSG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only females of reproductive age will be included, given the nature of HSG.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• LaTasha Craig, MD

  University of Oklahoma Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Zornes, MHR

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study will be blinded in a manner that the research nurse, patient, and provider will not be aware of patient allocation at time of recruitment and enrollment. The patient will be assigned a unique study ID number and the randomization module in REDCap will be used to assign the participant to either the experimental (warm) or control (cold) group. The patient will remain blinded to the treatment allocation but the research nurse and performing provider will be unblinded to allow for correct choice and use of warm versus cold contrast media. As both the research nurse and provider will touch the HSG contrast media and be able to discern if it is cold or warm, it is impossible to maintain blinding of the research team.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patient will be randomized to warmed vs cold (room temperature) HSG,

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 10, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)