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Completed

NCT Number: NCT00956774

Comparison of Three Cannulas for Hysterosalpingography

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HSG with acorn-tipped cannula

Procedure

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

HSG with cervical vacuum cup

Procedure

cup placed over cervix to create vacuum pressure.

HSG with balloon catheter

Procedure

balloon inserted via catheter into cervic for dilation.

Primary outcomes

  1. pain scores

    Time frame: 15 minutes

Secondary outcomes

  1. the total duration of the procedure

    Time frame: 15 minutes

  2. direct fluoroscopic time

    Time frame: 15 minutes

  3. rates of vasovagal reaction

    Time frame: 15 minutes

  4. diagnostic quality of images obtained

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 11, 2009
Registry last updated
Apr 25, 2022

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.

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