Comparison of Three Cannulas for Hysterosalpingography
|Infertility||Procedure: HSG with acorn-tipped cannula Procedure: HSG with cervical vacuum cup Procedure: HSG with balloon catheter|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study|
- pain scores [ Time Frame: 15 minutes ]
- the total duration of the procedure [ Time Frame: 15 minutes ]
- direct fluoroscopic time [ Time Frame: 15 minutes ]
- rates of vasovagal reaction [ Time Frame: 15 minutes ]
- diagnostic quality of images obtained [ Time Frame: 1 month ]
|Study Start Date:||February 2009|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Balloon Catheter||
Procedure: HSG with balloon catheter
balloon inserted via catheter into cervic for dilation.
|Active Comparator: Cervical Vacuum Cup||
Procedure: HSG with cervical vacuum cup
cup placed over cervix to create vacuum pressure.
|Active Comparator: acorn-tipped cannula||
Procedure: HSG with acorn-tipped cannula
Use of acorn-tipped cannula for HSG to evaluate tubal patency
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956774
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28203|
|Principal Investigator:||Sara Lane, MD||Carolinas Medical Center|