NCT05419921终止不适用
Comparison of the Diagnostic Accuracy of Hysterosalpingo-lidocaine-foam Sonography Versus Hysterosalpingography in Tubal Patency Assessment to the Gold Standard of Laparoscopy and Dye Testing
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.
研究概览
简要总结
This is a cross-sectional study that compares the diagnostic accuracy of Hysterosalpingo-lidocaine-foam sonography combined with power doppler (HyLiFoSy-PD) in the assessment of tubal patency, with the diagnostic accuracy of hysterosalpingogram (HSG), and to the gold standard of laparoscopy and dye testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age group (18-40)
- •Informed signed Written consent.
- •Scheduled for LDT as a part of their infertility management
- •Have undergone HSG in the previous 5 years with the availability of good-quality HSG images.
- •No incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
排除标准
- •LDT scheduled for a therapeutic purpose due to a known tubal or ovarian pathology
- •Lack of good-quality HSG images.
- •Withdrawal of consent.
- •Using contraception
- •Women outside reproductive age
- •Known allergy to lidocaine
- •Active pelvic inflammatory disease
- •Undiagnosed genital tract bleeding.
- •Evident tubal pathology (such as hydrosalpinx) or pregnancy diagnosed by transvaginal ultrasound (TV-US) prior to performing HyLiFoSy-PD 10- Incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
结局指标
主要结局
Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.
时间窗: July 2022- June 2024
次要结局
- Incidence and rate of potential complications for example: vasovagal and allergic reactions, venous intravasation(July 2022- June 2024)
- Evaluate the procedure associated pain(July 2022- June 2024)
- Evaluate the procedure duration(July 2022- June 2024)
- Percentage of failed or inconclusive attempts and possible reasons for that(July 2022- June 2024)
研究者
Islam Tarek Elkhateb
Assistant lecturer
NewGiza University
研究点 (1)
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