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

RecruitingEARLY Phase 1Ages 18 Years - 45 YearsFemaleUniversity of Oklahoma
NCT07226310 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Warmed HSG
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Where

1 site
University of Oklahoma Health Center
Oklahoma City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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