Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Diagnostic
|Official Title:||Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy|
- diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal pathologies [ Time Frame: participants will be followed by laparoscopy in 6 month after HSG ] [ Designated as safety issue: No ]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.
- diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal patency [ Time Frame: participants will be followed by laparoscopy in 6 month after HSG ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: real-time fluoroscopy
evaluating the tubal patency and pathology under fluoroscopy real-timely
Procedure: diagnose under real-time fluoroscopy
radiologists evaluating the tubal patency under fluoroscopy real-timely.Findings of fluoroscopy were blind to the investigators when the static radiographs were re-analyzed by the same team of radiologists.
Other Name: dynamic fluoroscopy
No Intervention: respective image
evaluating the tubal patency and pathology by Two supine and two oblique static images.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537276
|Taizhou Hospital of Zhejiang Province|
|LinHai, Zhejiang, China, 317000|
|Study Director:||Ying-Zi Mao, MD||Taizhou Hospital of Zhejiang Province|