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

Peking University First Hospital380 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

380

Conditions

Four Dimensional Hysterosalpingo-contrast Sonography Tubal Patency

Interventions

four dimensional hysterosalpingo-contrast sonographyDEVICE

compare accuracy and tolerability of 4D-HyCoSy with that of laparoscopy and chromotubation

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Sensitivity and specificity of four-dimensional hysterosalpingo-contrast sonography with SonoVue

Sensitivity, specificity, accuracy, positive predictive value, negative predictive value

Time frame: at least one year

Secondary Outcomes

side effects and complications of four-dimensional hysterosalpingo-contrast sonography

the intensity of pain perception, vaginal bleeding, fever, pelvic inflammatory diseases，peritonitis，and the pregnancy outcomes