Comparison of Three Cannulas for Hysterosalpingography

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: HSG with balloon catheter; Procedure: HSG with acorn-tipped cannula; Procedure: HSG with cervical vacuum cup

• Registration Number: NCT00956774
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2013-02
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balloon Catheter	HSG with balloon catheter	-
acorn-tipped cannula	HSG with acorn-tipped cannula	-
Cervical Vacuum Cup	HSG with cervical vacuum cup	-

Primary Outcome Measures

Name	Time	Method
pain scores	15 minutes

Secondary Outcome Measures

Name	Time	Method
the total duration of the procedure	15 minutes
direct fluoroscopic time	15 minutes
rates of vasovagal reaction	15 minutes
diagnostic quality of images obtained	1 month

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States