Feasibility of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency

• Conditions: Four Dimensional Hysterosalpingo-contrast Sonography; Tubal Patency

• Registration Number: NCT02505555
• Lead Sponsor: Peking University First Hospital

Brief Summary

The purpose of this study is to summarize our experience with and to evaluate the feasibility of transvaginal four-dimensional hysterosalpingo-contrast sonography using SonoVue (4D-HyCoSy) for assessment of fallopian tubal patency, women attending the fertility clinic are recruited. All of the patients are tried to be examined with 4D-HyCoSy,some of who undergone laparoscopy and dye. Then the results of 4D-HyCoSy and lap and dye are compared. All of the patients will be followed up. The complications of 4D-HyCoSy will be evaluated and the pregnancy outcomes will be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Status Verified: 2015-07
• Study First Submitted: 2015-07-04
• Study First Submitted QC: 2015-07-21
• Last Update Submitted: 2015-07-21
• Study First Posted: 2015-07-22
• Last Update Posted: 2015-07-22
• Primary Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 380

Inclusion Criteria

• Women who have infertility and need to evaluate tubal patency.

Exclusion Criteria

1. vaginal bleeding;
2. acute or subacute inflammation of the reproductive system;
3. uterine malignancies;
4. allergies to the medications used in the examination, such as lidocaine, atropine, and sulfur hexafluoride

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of four-dimensional hysterosalpingo-contrast sonography with SonoVue	at least one year	Sensitivity, specificity, accuracy, positive predictive value, negative predictive value

Secondary Outcome Measures

Name	Time	Method
side effects and complications of four-dimensional hysterosalpingo-contrast sonography	at least one year	the intensity of pain perception, vaginal bleeding, fever, pelvic inflammatory diseases，peritonitis，and the pregnancy outcomes

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China