Self-controlled Study Between 4-hour and 24-hour Delayed Radiographs in HSG Using OSCM
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 4-hour delayed radiographs The follow-up radiographs was taken 4 h after the HSG operation. |
Diagnostic Test: Add 4-hour delayed radiographs
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 .
|
Outcome Measures
Primary Outcome Measures
- Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs. [The evaluation was performed within 1 day after completion of the 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.
Secondary Outcome Measures
- Difference in the diagnosis of patency of proximal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs [The evaluation was performed within 1 day after completion of the 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.
- Difference in the diagnosis of patency of distal fallopian tube between 4 hours delayed radiographs and 24 hours delayed radiographs [The evaluation was performed within 1 day after completion of the 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.
- Difference in the diagnosis of pelvic lesions between 4 hours delayed radiographs and 24 hours delayed radiographs. [The evaluation was performed within 1 day after completion of the 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.
Other Outcome Measures
- The incidence of adverse events and serious adverse events. [Within one month after hysterosalpingography procedure.]
Adverse event levels were assessed according to CTCAE 5.0.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Having spontaneous ovulation or inducing ovulation;
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Infertility lasting for 12 months;
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Conforms to the indications of hysterosalpingography;
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Understand and sign the informed consent;
Exclusion Criteria:
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Iodine allergy or hyperthyroidism
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Acute genital tract inflammation or abnormal leucorrhea examination;
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Abnormal vaginal bleeding;
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Fever or preoperative temperature higher than 37.5℃ within 3 days before angiography;
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Severe insufficiency of cardiopulmonary or liver function;
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During pregnancy and menstruation;
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With complications that may cause subjects to be unable to follow the study plan or even endanger the patient's safety or social environment;
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Patients who are participating in other clinical studies or who are not suitable for inclusion in this study due to other reasons considered by the researchers.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Women's Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- Women's Hospital School Of Medicine Zhejiang University
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
Investigators
- Study Chair: Yimin Zhu, Women's Hospital School Of Medicine Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-20200261-R