search
Back to results

Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
diagnose under real-time fluoroscopy
Sponsored by
YiYang Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring hysterosalpingography, Fluoroscopy, diagnostic accuracy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women seeking for a infertility laparoscopy

Exclusion Criteria:

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

Sites / Locations

  • Taizhou Hospital of Zhejiang Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

real-time fluoroscopy

respective image

Arm Description

evaluating the tubal patency and pathology under fluoroscopy real-timely

evaluating the tubal patency and pathology by Two supine and two oblique static images.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 12, 2012
Last Updated
February 22, 2012
Sponsor
YiYang Zhu
search

1. Study Identification

Unique Protocol Identification Number
NCT01537276
Brief Title
Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy
Official Title
Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
YiYang Zhu

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
hysterosalpingography, Fluoroscopy, diagnostic accuracy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigator
Allocation
Non-Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
real-time fluoroscopy
Arm Type
Experimental
Arm Description
evaluating the tubal patency and pathology under fluoroscopy real-timely
Arm Title
respective image
Arm Type
No Intervention
Arm Description
evaluating the tubal patency and pathology by Two supine and two oblique static images.
Intervention Type
Procedure
Intervention Name(s)
diagnose under real-time fluoroscopy
Other Intervention Name(s)
dynamic fluoroscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal pathologies
Description
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.
Time Frame
participants will be followed by laparoscopy in 6 month after HSG
Secondary Outcome Measure Information:
Title
diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal patency
Description
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.
Time Frame
participants will be followed by laparoscopy in 6 month after HSG

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women seeking for a infertility laparoscopy Exclusion Criteria: acute low reproductive duct infection a known hypersensitivity to iodine genital bleeding or malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Zi Mao, MD
Organizational Affiliation
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Taizhou Hospital of Zhejiang Province
City
LinHai
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy

We'll reach out to this number within 24 hrs