Study Comparing Warmed Versus Room-Temperature Contrast Dye During Hysterosalpingogram HSG Effects on Pain and Fallopian Tube Spasm in Women with Infertility

What this Trial Is About

The trial focuses on women with infertility who need an assessment of their fallopian tubes using hysterosalpingogram HSG, a procedure that involves placing a catheter in the cervix to inject contrast dye for imaging. The study aims to compare the effects of warming the contrast dye versus using it at room temperature on pain levels and tubal spasms, which can cause false positives for tubal blockage. This randomized controlled trial explores whether warmed dye reduces discomfort and improves test accuracy in women with normal uterine anatomy. Participants are randomly assigned to receive either warmed contrast dye or standard room-temperature dye during their HSG procedure, which is scheduled according to their menstrual cycle typically days 5 to 10. The procedure is performed by trained clinicians following standard clinic protocols. Participants will complete pain questionnaires before and after the procedure, while the research team collects clinical data and imaging results to compare outcomes between the two groups. Participants are involved in a single study visit lasting about one hour, during which the HSG is performed and questionnaires are completed. Researchers will collect medical history and demographic information from electronic health records and enter all data securely for analysis. Key outcomes include patient-reported pain one hour after the procedure and the rate of tubal spasms observed during imaging. Participants can withdraw at any time without affecting their clinical care, and results are shared with patients and their fertility providers after the procedure.

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