Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
NCT Number: NCT00956774
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Charlotte, North Carolina, 28203, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of acorn-tipped cannula for HSG to evaluate tubal patency
cup placed over cervix to create vacuum pressure.
balloon inserted via catheter into cervic for dilation.
Time frame: 15 minutes
Time frame: 15 minutes
Time frame: 15 minutes
Time frame: 15 minutes
Time frame: 1 month
Wake Forest University Health Sciences
Other
Comparison of Three Cannulas for Hysterosalpingography: A Prospective, Randomized Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06659692
Genital Diseases, Infertility
Toronto, Ontario, Canada
View Trial DetailsNCT06924437
Abnormal Uterine Bleeding (AUB), Endometrial Polyp
Sohag, Egypt
View Trial DetailsNCT01511588
Adolescents, Amenorrhea
Bethesda, Maryland, United States
View Trial DetailsNCT07399535
Adnexal Diseases, Cysts
Karachi, Sindh, Pakistan
View Trial Details