Prospective Self-controlled Study for Shortening the Time Before Taking Delayed Radiographs With Iodized Oil Hysterosalpingography
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having spontaneous ovulation or inducing ovulation;
- •Infertility lasting for 12 months;
- •Conforms to the indications of hysterosalpingography;
- •Understand and sign the informed consent;
排除标准
- •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.
结局指标
主要结局
Difference in diagnosis of fallopian tube patency between 4 hours delayed radiographs and 24 hours delayed radiographs.
时间窗: 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.
次要结局
- 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.)
- 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.)
- 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.)