Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: diagnose under real-time fluoroscopy

• Registration Number: NCT01537276
• Lead Sponsor: YiYang Zhu

Brief Summary

As an essential step of the infertile work-up, hysterosalpingogram (HSG) has some advantages including the lack of need for anesthesia, a non-invasive procedure with less cost and relative easy to put into practice. However, it would be failed to detect the extra-tubal and peritoneal pathology and would be also difficult to distinguish the obstruction caused by the spasm of intramural segment. Obviously, imaging quality plays a key role in diagnostic accuracy of the HSG, studies had taken four roentgenograms and combined with the fluoroscopy were reported a higher sensitivity and specificity than those only taken two images in the examination. And hybridized radiography with CT or MRI system may provide the good-quality of the HSG. It is also reported that the sonosalpingography (SSG), which detect the tubal patency in real time, can show pelvic pathologies better than HSG. However, no parallel study was designed to verify the hypothesis that combined the fluoroscopy and taken more images can improving the diagnostic quality of the HSG. The aim of this study is to evaluate whether the accuracy of HSG can be improved by real-time evaluating under the fluoroscopy.

Detailed Description

Tubal disease is responsible for 30-40% of female infertility in China. The lesions of fallopian tube include occlusion, hydrosalpinx, and adhesion. Many techniques were developed to assess the tubal pathology. Although laparoscopy can visualize the morphological abnormalities of fallopian tubes directly and is widely accepted as a gold standard for investigation of tubal patency, it is an invasive procedure and may carry of some risk. Hysterosalpingography, which uses contrast media and radiographic techniques to visualize the uterine cavity and tubal lumen, remains the first line screening since it was described by Carey.

As an essential step of the infertile work-up, HSG has some advantages including the lack of need for anesthesia, a non-invasive procedure with less cost and relative easy to put into practice. Additional, HSG may have a potential therapeutic effect with the use of oil soluble contrast media for examination. However, it would be failed to detect the extra-tubal and peritoneal pathology and would be also difficult to distinguish the obstruction caused by the spasm of intramural segment. In an early meta-analysis, HSG was regard as the limited use of evaluating the peritubal adhesions because of its low sensitivity. But in a recently small sample's report, the authors argued that the diagnostic accuracy of HSG in peritubal adhesion can be improved by analyzing some special signs on the radiographs.

Obviously, imaging quality plays a key role in diagnostic accuracy of the HSG, studies had taken four roentgenograms and combined with the fluoroscopy were reported a higher sensitivity and specificity than those only taken two images in the examination. And hybridized radiography with CT or MRI system may provide the good-quality of the HSG. It is also reported that the sonosalpingography (SSG), which detect the tubal patency in real time, can show pelvic pathologies better than HSG. However, no parallel study was designed to verify the hypothesis that combined the fluoroscopy and taken more images can improving the diagnostic quality of the HSG. The aim of this study is to evaluate whether the accuracy of HSG can be improved by real-time evaluating under the fluoroscopy.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-02
• Study First Submitted: 2012-02-12
• Study First Submitted QC: 2012-02-22
• Last Update Submitted: 2012-02-22
• Study First Posted: 2012-02-23
• Last Update Posted: 2012-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 263

Inclusion Criteria

• women seeking for a infertility laparoscopy

Exclusion Criteria

• acute low reproductive duct infection
• a known hypersensitivity to iodine
• genital bleeding or malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
real-time fluoroscopy	diagnose under real-time fluoroscopy	evaluating the tubal patency and pathology under fluoroscopy real-timely

Primary Outcome Measures

Name	Time	Method
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal pathologies	participants will be followed by laparoscopy in 6 month after HSG	The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of HSG for diagnosis of tubal pathlogies. The pathlogies of tube is classified as the normal HSG, the proximal tubal obstruction, the hydrosalpinx (distal tubal obstruction), and the peritubal adhesions (at least one tube is patent) ,which is confirmed by laparoscopy in six month after HSG.

Secondary Outcome Measures

Name	Time	Method
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal patency	participants will be followed by laparoscopy in 6 month after HSG	The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of HSG for diagnosis of tubal patency. The patency of tube is classified as two-sided occlusion, one-sided occlusion and two side patency,which is confirmed by laparoscopy in six month after HSG.

Trial Locations

Locations (1)

Taizhou Hospital of Zhejiang Province; 🇨🇳 LinHai, Zhejiang, China