Clinical trial NCT01537276: Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy
Official title: Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: hysterosalpingography
Fluoroscopy
diagnostic accuracy
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 263
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal pathologies
timeFrame: participants will be followed by laparoscopy in 6 month after HSG
Secondary outcomes:
measure: diagnostic sensitivity, specificity, positive predictive value, negative predictive value of HSG in detecting tubal patency
timeFrame: participants will be followed by laparoscopy in 6 month after HSG
Other outcomes:
Locations:
city: LinHai
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Ying-Zi Mao, MD
role: STUDY_DIRECTOR
References: