Comparison of Three Cannulas for Hysterosalpingography

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956774
• Other study ID #: Comparison of 3 Cannulas - HSG
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2013
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scores		15 minutes
Secondary	the total duration of the procedure		15 minutes
Secondary	direct fluoroscopic time		15 minutes
Secondary	rates of vasovagal reaction		15 minutes
Secondary	diagnostic quality of images obtained		1 month