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

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 enrolled 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 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. The research coordinator or treating physician will obtain informed consent.

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 post-procedure questionnaire.

All data will be collected by the research nurse and entered into RedCap by a member of the study team in a deidentified coded manner.

A single study visit lasting approximately 1 hour will be conducted. This includes the time to meet with the nurse and sign consents and then have HSG procedure performed.

This study will be blinded in a manner that the research nurse, patient, and provider will not be aware of patient allocation at time of recruitment and enrollment. 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 remain blinded to the treatment allocation but the research nurse and performing provider will be unblinded to allow for correct choice and use of warm versus cold contrast media. As both the research nurse and provider 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.