Comparison of Three Cannulas for Hysterosalpingography

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study

Conditions
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Infertility

Intervention / Treatment
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* Procedure: HSG with acorn-tipped cannula
* Procedure: HSG with cervical vacuum cup
* Procedure: HSG with balloon catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balloon Catheter<br> | Procedure: HSG with balloon catheter<br>* balloon inserted via catheter into cervic for dilation.<br>|
| Active Comparator: Cervical Vacuum Cup<br> | Procedure: HSG with cervical vacuum cup<br>* cup placed over cervix to create vacuum pressure.<br>|
| Active Comparator: acorn-tipped cannula<br> | Procedure: HSG with acorn-tipped cannula<br>* Use of acorn-tipped cannula for HSG to evaluate tubal patency<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSG, Cannula, HSG procedure, infertility evaluation