Infertility Clinical Trial
Official title:
Improve Hysterosalpingographic Accuracy by Real-time Fluoroscopy
Verified date | February 2012 |
Source | Taizhou Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 263 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - women seeking for a infertility laparoscopy Exclusion Criteria: - acute low reproductive duct infection - a known hypersensitivity to iodine - genital bleeding or malignancy |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
China | Taizhou Hospital of Zhejiang Province | LinHai | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
YiYang Zhu |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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