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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Warmed HSG

    Drug

    The intervention is warming the HSG constrast.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Cold HSGNo intervention 0 interventions
Group B: Warm HSGActive comparator 1 intervention

Trial outcomes

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.

Time frame
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.

Time frame
Measured at the time of HSG procedure

Other outcomes

Sponsors and contacts

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