HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency: a Prospective Case-control Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Study of tubal patency and establish the concordance of results between HyFoSy and HSG.
研究概览
简要总结
Observational, single-center, prospective case-control study, in which each patient is his own control.
It focuses on the study of tubal patency and establishing the agreement of results between HyFoSy and HSG.
详细描述
Observational, single-center, case-control study in which tubal pathology is studied in the context of a Basic Sterility Study.
The main objective of this study is to demonstrate the concordance of this new diagnostic test (HyFoSy) with HSG, which is the common technique to visualize tubal patency. Once demonstrated concordance, we also want to carry out a cost-effectiveness study and demonstrate through different scales the greater ease of the test, less time to perform and less pain for the patient.
It is a study in which the patients are women between 18-39 years old, undergoing study for primary sterility, with a BMI <30, AMH> 0.6 (good ovarian reserve).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18-39 years, under study for primary sterility, with BMI <30, AMH> 0.6 (good ovarian reserve), subsidiaries of Conjugal or Donor IA, according to the 2019 SAS Reproduction Guide.
排除标准
- •Women <19 or> 39 years old, BMI> 30, secondary sterility, previous tubal sterilization, that is, the ART exclusion criteria according to the 2019 SAS Reproduction Guide.
结局指标
主要结局
Study of tubal patency and establish the concordance of results between HyFoSy and HSG.
时间窗: Up to 48 weeks.
Concordance study between HyFoSy and HSG. It is a qualitative study (yes / no).
次要结局
- Rate of occurrence of complications in the patients included in the study.(Up to 48 weeks.)
- Time costs of performing HyFoSy versus HSG.(Up to 48 weeks.)