跳至主要内容
临床试验/NCT03507322
NCT03507322撤回不适用

Ultrasound Study Through Uterine Texturization to Predict Pregnancy After Blastocyst Transfer in Patients Undergoing Hormone Replacement Therapy (HRT) Cycles With Donor Oocytes

IVI Sevilla1 个研究点 分布在 1 个国家开始时间: 2017年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Chemical pregnancy rate

研究概览

简要总结

This study is focused on analysing the application of ultrasound scanning techniques as new biomarkers in reproductive medicine. Those biomarkers are based on the analysis of ultrasound texture in different areas of uterine tissue, using 2D/3D ultrasound scanning. Investigators will use the algorithm Text® to analyse the ultrasound texture of the endometrium and myometrium. The aim of the project is to study if it is possible to obtain measurable, objective and reproducible data in healthy volunteers which can be used to predict pregnancy and determine the best moment to perform embryo transfer in assisted reproductive technology (ART) cycles

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Body mass index (BMI) between 18 and 30 kg/m2
  • Not taking the contraceptive pill in a previous cycle
  • Non-pregnant: beta human chorionic gonadotropin (HCG) test with negative result at the beginning of the study)
  • No previous history of inflammatory diseases, circulatory diseases, abdomen or pelvic diseases
  • Physical gynecological exploration without pathological findings
  • Gynecological ultrasound study of the uterus with a normal result

排除标准

  • Ultrasound studies with technical defects in image acquisition
  • Simultaneous participation in other studies
  • Previous participation in other study which can affect the results of the present study

结局指标

主要结局

Chemical pregnancy rate

时间窗: Around 14 days after embryo transfer

Positive result in beta HCG test indicating pregnancy

Clinical miscarriage rate

时间窗: Up to 20 weeks after embryo transfer

Interruption of pregnancy after confirming clinical pregnancy using ultrasound scanning

beta HCG level

时间窗: Around 14 days after embryo transfer

Level of beta HCG in the test performed to detect pregnancy

Clinical pregnancy rate

时间窗: Around 5-6 weeks after embryo transfer

Detection of gestational sac through ultrasound scanning indicating clinical pregnancy

Biochemical miscarriage rate

时间窗: Up to one month after embryo transfer

Interruption of pregnancy after a positive result in the beta HCG test

次要结局

未报告次要终点

研究者

发起方
IVI Sevilla
申办方类型
Other
责任方
Sponsor

研究点 (1)

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