Comparison of Three Cannulas for Hysterosalpingography
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|ClinicalTrials.gov Identifier: NCT00956774|
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : February 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Procedure: HSG with acorn-tipped cannula Procedure: HSG with cervical vacuum cup Procedure: HSG with balloon catheter||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
|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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956774
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28203|
|Principal Investigator:||Sara Lane, MD||Carolinas Medical Center|