Comparison of Three Cannulas for Hysterosalpingography

• the total duration of the procedure [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
• direct fluoroscopic time [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
• rates of vasovagal reaction [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
• diagnostic quality of images obtained [ Time Frame: 1 month ] [ Designated as safety issue: No ]

The aim of this study is to compare the three commonly used hysterosalpingography (HSG) injection devices on the basis of patient pain perception, total fluoroscopic and procedural time, and side effects in a prospective, randomized study. An important and novel secondary outcome is the comparison of the quality of images obtained with these three devices. The investigators hypothesize that the balloon catheter and cervical vacuum cup will be less painful than the acorn tipped cannula and that there will be no difference in image quality between the three groups.

This study is a prospective, randomized trial of women undergoing HSG as part of their infertility evaluation. At the time of scheduling, the patient will be randomized to either the cervical vacuum cup, balloon catheter (H/S catheter set, UA Medical, Biotech America), or the acorn-tipped cannula using stratified blocked randomization. 100 subjects will be randomized to one of the three cannulas. Patients will be stratified into 4 groups representative of the four reproductive endocrinologists in order to overcome any potential interoperator bias.

Four reproductive endocrinologists will perform the HSG procedures in a standardized fashion. Fluoroscopy will ensure proper location of the cannula and check for uterine filling of contrast. Digital images will document tubal filling and spilling of contrast. The patient will be rolled to right and left side to confirm free spillage of contrast in the peritoneal cavity. The last image will be taken after the balloon tip is deflated or the cannulas are removed to best evaluate the lower uterine segment.

• Procedure: HSG with acorn-tipped cannula
  Use of acorn-tipped cannula for HSG to evaluate tubal patency
• Procedure: HSG with cervical vacuum cup
  cup placed over cervix to create vacuum pressure.
• Procedure: HSG with balloon catheter
  balloon inserted via catheter into cervic for dilation.

• Active Comparator: Balloon Catheter
  Intervention: Procedure: HSG with balloon catheter
• Active Comparator: Cervical Vacuum Cup
  Intervention: Procedure: HSG with cervical vacuum cup
• Active Comparator: acorn-tipped cannula
  Intervention: Procedure: HSG with acorn-tipped cannula

Inclusion Criteria:

• Women undergoing HSG at an academic medical center

Exclusion Criteria:

• Contrast media allergy
• Prior LEEP (Loop Electrosurgical Excision Procedure) or other cervical procedure
• Contraindication to NSAID use
• Known active pelvic infection
• Active vaginal bleeding