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Comparison of Three Cannulas for Hysterosalpingography

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00956774
Enrollment
114
Registered
2009-08-11
Start date
2009-02-28
Completion date
2010-02-28
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

HSG, Cannula, HSG procedure, infertility evaluation

Brief 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.

Detailed 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.

Interventions

PROCEDUREHSG with acorn-tipped cannula

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

PROCEDUREHSG with cervical vacuum cup

cup placed over cervix to create vacuum pressure.

PROCEDUREHSG with balloon catheter

balloon inserted via catheter into cervic for dilation.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
pain scores15 minutes

Secondary

MeasureTime frame
the total duration of the procedure15 minutes
direct fluoroscopic time15 minutes
rates of vasovagal reaction15 minutes
diagnostic quality of images obtained1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026