Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
YiYang Zhu, Taizhou Hospital
ClinicalTrials.gov Identifier:
NCT01537276
First received: February 12, 2012
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Infertility
Procedure: diagnose under real-time fluoroscopy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Taizhou Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 263
Study Start Date: January 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537276

Locations
China, Zhejiang
Taizhou Hospital of Zhejiang Province
LinHai, Zhejiang, China, 317000
Sponsors and Collaborators
YiYang Zhu
Investigators
Study Director: Ying-Zi Mao, MD Taizhou Hospital of Zhejiang Province
  More Information

No publications provided

Responsible Party: YiYang Zhu, Center for reproductive medicine, Taizhou Hospital
ClinicalTrials.gov Identifier: NCT01537276     History of Changes
Other Study ID Numbers: taizhou201101
Study First Received: February 12, 2012
Last Updated: February 22, 2012
Health Authority: China: Ministry of Health

Keywords provided by Taizhou Hospital:
hysterosalpingography
Fluoroscopy
diagnostic accuracy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014