Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

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.
    

Intervention name(s): diagnose under real-time fluoroscopy
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): dynamic fluoroscopy
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: hysterosalpingography; Fluoroscopy; diagnostic accuracy