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

NCT ID: NCT07226310

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

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.

Detailed Description

Research materials will include obtaining patient past medical history at time of the patient screening and recruitment, via utilization of Epic to search for demographic factors including age, height, weight, BMI, race/ethnicity, duration of infertility, past medical history, and gynecologic/obstetric history.

Post-procedure images from the HSG/report of the HSG findings will be saved in Epic as per usual standard clinical practice. HSG findings will be transcribed with prior demographics/history into a PHI-safe RedCap. No biospecimens will be collected under this protocol.

Patients undergoing fertility treatment that are recommended to undergo HSG as part of their evaluation will be referred to a dedicated research nurse (RN) for eligibility screening and informed consent.

Once found to be meeting inclusion criteria, the patient will be enrolled and scheduled for HSG as appropriate for their menstrual cycle and clinical care. Typically, patients are scheduled during cycle day 5-10 of their menstrual cycle for best study image quality.

Once scheduled, the patient will be randomized to warmed vs cold (room temperature) HSG. The principal investigator will create a computer-generated randomization table (1:1) using block randomization with randomly varying block size of 4 and 6 without stratification. The research coordinator or treating physician will obtain informed consent.

Study team members will have electronic access to the table of randomization within the secure REDCap randomization module and will assign each patient to a single-blinded treatment group once informed consent is obtained.

HSG will be performed in accordance with clinic policy by a physician or physician assistant trained in the procedure and interpretation of study results. Patients will be asked to complete a post-procedure questionnaire.

All data will be collected by the research nurse and entered into RedCap by a member of the study team in a deidentified coded manner.

A single study visit lasting approximately 1 hour will be conducted. This includes the time to meet with the nurse and sign consents and then have HSG procedure performed.

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.

The control group (cold contrast) is the current standard of care and is included in this study as a control to allow for comparison with the experimental (warm contrast) group. All patients will obtain an HSG via the same standardized technique at OURM.

Patients may withdraw from the study at any time without repercussions and will be allowed to undergo HSG with standard of care practices at OURM at their discretion. Withdrawal of participation in the study will not change the course of a patient's fertility evaluation or treatment. If the study were to end prematurely, all patients will maintain scheduled appointments for HSG with standard practice methods (cold contrast dye) to be used as per clinic protocol.

All participant recruitment and data collection activities including consenting, interventions, chart reviews, and data analysis will occur at OU Reproductive Medicine clinic (OURM) and via Epic clinical chart review as needed to obtain study data. Data analysis will be conducted in the OUHSC Department of Biostatistics and Epidemiology using data exported from the HIPAA compliant REDCap database and stored on a secure server.

Patients and their fertility provider will all be informed of their HSG results after completion of the procedure as per clinic protocol as part of their fertility evaluation. Patients will be informed of their HSG results after completion of a post-procedure pain questionnaire.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cold HSG

HSG contrast will be standard, room-temperature

Group Type: NO_INTERVENTION

No interventions assigned to this group

Warm HSG

HSG constrast will be warmed.

Group Type: ACTIVE_COMPARATOR

Warmed HSG

Intervention Type: DRUG

The intervention is warming the HSG constrast.

Interventions

Warmed HSG

The intervention is warming the HSG constrast.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LaTasha Craig, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma Health Center

Locations

University of Oklahoma Health Center

Oklahoma City, Oklahoma, United States

Countries

United States

Central Contacts

Christy Zornes, MHR

Role: CONTACT

Phone: (405) 271-8001

Email: christy-zornes@ou.edu

Facility Contacts

Christy Zornes, MHR

Role: primary

Other Identifiers

18943

Identifier Type: -

Identifier Source: org_study_id