InfertilityEarly Phase 1HEATNCT07226310
The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study
A Early Phase 1 study testing Warmed HSG in people with Infertility, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Warmed HSG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Women ages 18-45 undergoing tubal assessment via HSG.
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma Health Center
Oklahoma City, Oklahoma, 73104
Christy Zornes, MHR, 405-271-8001 ext. 48137, christy-zornes@ou.edu
LaTasha Craig, MD
About this study
Official title: The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study: A Randomized Controlled Trial
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.
Read the 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 consented 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 (body temperature) 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.
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 pre- and post-procedure questionnaire.
All data will be collected by the research team and entered into RedCap. A single study visit lasting approximately 1 hour will be conducted. 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 be blinded to the treatment allocation, but the research team will be unblinded to allow for correct choice and use of warm versus cold contrast media. As research team members 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
- Being tested
- Warmed HSG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warmed HSGDrug
The intervention is warming the HSG constrast.
| Study group | Role | What they receive |
|---|---|---|
| Cold HSG | No intervention | HSG contrast will be standard, room-temperature |
| Warm HSG | Active comparator | HSG constrast will be warmed. Receives: Drug: Warmed HSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured 1 hour after HSG procedure
Secondary outcomes (1)
Rate of unilateral and bilateral proximal fallopian tube occlusion
The event proportions of unilateral and bilateral proximal fallopian tube occlusion at the time of HSG procedure will be compared between warms versus cold contrast media groups using chi-square tests or Fisher's exact tests as appropriate.
Measured: Measured at the time of HSG procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patient will be randomized to warmed vs cold (room temperature) HSG,
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LaTasha Craig, MD, Principal investigator, University of Oklahoma Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226310
- Sponsor's protocol ID
- 18943P
- Acronym
- HEAT
- Status last verified
- Jul 2026
- First submitted
- 3 Nov 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07226310
- Acronym / sponsor ID
- HEAT / 18943P
- Conditions
- Infertility
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 consented 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 (body temperature) 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.
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 pre- and post-procedure questionnaire.
All data will be collected by the research team and entered into RedCap. A single study visit lasting approximately 1 hour will be conducted. 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 be blinded to the treatment allocation, but the research team will be unblinded to allow for correct choice and use of warm versus cold contrast media. As research team members 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The patient will be randomized to warmed vs cold (room temperature) HSG,
| Arm | Type | Receives |
|---|---|---|
| Cold HSG | No intervention | –HSG contrast will be standard, room-temperature |
| Warm HSG | Active comparator | Drug: Warmed HSGHSG constrast will be warmed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Women ages 18-45 undergoing tubal assessment via HSG.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warmed HSGThe intervention is warming the HSG constrast. | Drug | Warm HSG |
Primary outcome
Post-HSG Pain Questionnaire
Time frame: Measured 1 hour after HSG procedure
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.
1 secondary outcome
Rate of unilateral and bilateral proximal fallopian tube occlusion
Time frame: Measured at the time of HSG procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LaTasha Craig, MD principal investigator
University of Oklahoma Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Warmed HSG in people with Infertility, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christy Zornes, MHR ((405) 271-8001 ext. 48137, christy-zornes@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-HSG Pain Questionnaire (time frame: Measured 1 hour after HSG procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.