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

ConditionInfertility
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Oklahoma

About this 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.

Eligibility criteria

Qualifiers

None

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Warmed HSG

Treatment groups

240 Participants
are divided into 2 treatment groups

Sponsors and collaborators