Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy

NCT ID: NCT01537276

Last Updated: 2012-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-11-30

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.

Conditions

Infertility

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

real-time fluoroscopy

evaluating the tubal patency and pathology under fluoroscopy real-timely

Group Type: EXPERIMENTAL

diagnose under real-time fluoroscopy

Intervention Type: PROCEDURE

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.

respective image

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

dynamic fluoroscopy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

YiYang Zhu

OTHER

Sponsor Role: lead

Responsible Party

YiYang Zhu

Center for reproductive medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ying-Zi Mao, MD

Role: STUDY_DIRECTOR

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Locations

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, China

Countries

China

Other Identifiers

taizhou201101

Identifier Type: -

Identifier Source: org_study_id