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| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
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Background of the study:
Hysterosalpingography (HSG) is widely used for the female infertility workup. Many studies have demonstrated that the use of oil-soluble contrast medium (OSCM) ethiodized oil for HSG surgery can improve pregnancy rates. However,The 24-hour delayed radiographs of OSCM HSG also brought some inconvenience to the patients , for example, patients need to make two trips to the hospital.
Objective of the study:
The purpose of this study was to compare OSCM HSGs using 4-hour and 24-hour delayed radiographs in terms of diagnosing tubal patency and identifying the presence of pelvic adhesions.
Study design:
Prospective, open label, self - controlled study
Study population:
Infertile patients scheduled for an OSCM HSG
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-hour delayed radiographs | Other | The follow-up radiographs was taken 4 h after the HSG operation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Add 4-hour delayed radiographs | Diagnostic Test | Normal patients only need to take delayed radiographs 24h after HSG operation. In this study, 4-hour delayed radiographs were added to the 24-hour delayed radiographs, so that the patients had to take one more delayed radiographs . |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs. | The diagnostic results of 4 hours delayed radiographs and 24 hours delayed radiographs were evaluated by two radiologists with more than 5 years' working experience. In case of any dispute, the two doctors reached an agreement after discussion. The results were defined as : completely consistent; mostly consistent;partly consistent;completely different. | The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the diagnosis of patency of proximal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs | The diagnostic results of 4 hours delayed radiographs and 24 hours delayed radiographs were evaluated by two radiologists with more than 5 years' working experience. In case of any dispute, the two doctors reached an agreement after discussion. The results were defined as : completely consistent; mostly consistent;partly consistent;completely different. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events and serious adverse events. | Adverse event levels were assessed according to CTCAE 5.0. | Within one month after hysterosalpingography procedure. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yimin Zhu | Contact | 057189992071 | zhuyim@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yimin Zhu | Women's Hospital School Of Medicine Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs. |
| Difference in the diagnosis of patency of distal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs | The diagnostic results of 4 hours delayed radiographs and 24 hours delayed radiographs were evaluated by two radiologists with more than 5 years' working experience. In case of any dispute, the two doctors reached an agreement after discussion. The results were defined as : completely consistent; mostly consistent;partly consistent;completely different. | The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs. |
| Difference in the diagnosis of pelvic lesions between 4 hours delayed radiographs and 24 hours delayed radiographs. | The diagnostic results of 4 hours delayed radiographs and 24 hours delayed radiographs were evaluated by two radiologists with more than 5 years' working experience. In case of any dispute, the two doctors reached an agreement after discussion. The results were defined as : completely consistent; mostly consistent;partly consistent;completely different. | The evaluation was performed within 1 day after completion of the 24 hours delayed radiographs. |