Comparison of Three Cannulas for Hysterosalpingography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-02-28

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.

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Balloon Catheter

Group Type ACTIVE_COMPARATOR

HSG with balloon catheter

Intervention Type PROCEDURE

balloon inserted via catheter into cervic for dilation.

Cervical Vacuum Cup

Group Type ACTIVE_COMPARATOR

HSG with cervical vacuum cup

Intervention Type PROCEDURE

cup placed over cervix to create vacuum pressure.

acorn-tipped cannula

Group Type ACTIVE_COMPARATOR

HSG with acorn-tipped cannula

Intervention Type PROCEDURE

Use of acorn-tipped cannula for HSG to evaluate tubal patency

Interventions

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HSG with acorn-tipped cannula

Use of acorn-tipped cannula for HSG to evaluate tubal patency

Intervention Type PROCEDURE

HSG with cervical vacuum cup

cup placed over cervix to create vacuum pressure.

Intervention Type PROCEDURE

HSG with balloon catheter

balloon inserted via catheter into cervic for dilation.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No