Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: diagnose under real-time 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 Type: Interventional
• Enrollment (Actual): 263
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • LinHai, Zhejiang, China, 317000
      • Taizhou Hospital of Zhejiang Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: dynamic fluoroscopy
No Intervention: respective image; evaluating the tubal patency and pathology by Two supine and two oblique static images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal pathologies	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.	participants will be followed by laparoscopy in 6 month after HSG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal patency	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.	participants will be followed by laparoscopy in 6 month after HSG

Collaborators and Investigators

• Sponsor: YiYang Zhu
• Investigators: Study Director: Ying-Zi Mao, MD, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: February 12, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Estimate): February 23, 2012
• Last Update Submitted That Met QC Criteria: February 22, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: diagnostic accuracy; Fluoroscopy; hysterosalpingography
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: taizhou201101