Self-controlled Study Between 4-hour and 24-hour Delayed Radiographs in HSG Using OSCM

Study Overview
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Brief Summary
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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

Official Title
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Prospective Self-controlled Study for Shortening the Time Before Taking Delayed Radiographs With Iodized Oil Hysterosalpingography

Conditions
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Infertility

Intervention / Treatment
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* Diagnostic Test: Add 4-hour delayed radiographs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having spontaneous ovulation or inducing ovulation; Infertility lasting for 12 months; Conforms to the indications of hysterosalpingography; Understand and sign the informed consent; Exclusion Criteria: Iodine allergy or hyperthyroidism Acute genital tract inflammation or abnormal leucorrhea examination; Abnormal vaginal bleeding; Fever or preoperative temperature higher than 37.5℃ within 3 days before angiography; Severe insufficiency of cardiopulmonary or liver function; During pregnancy and menstruation; With complications that may cause subjects to be unable to follow the study plan or even endanger the patient's safety or social environment; 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 4-hour delayed radiographs<br>The follow-up radiographs was taken 4 h after the HSG operation. | Diagnostic Test: Add 4-hour delayed radiographs<br>* 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 .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Hysterosalpingography, Oil-soluble contrast medium