NCT02189369Unknown不适用
Clinical Validation of a Diagnostic Test Which Measures the Endometrial Prostaglandins Liquid 24 Hours Before Embryo Transfer and That is Capable of Predicting a State of Endometrial Receptivity
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Igenomix
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- endometrial receptivity
研究概览
简要总结
This clinical validation study is being carried out to validate the efficacy of a test measuring the clinical application of prostaglandins present in the endometrial fluid in patients, 24 hours before the embryonic transfer. This test is capable of predicting endometrial receptivity without the need of performing a biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any IVF patient being treated for single or double embryo transfer
- •BMI: 20 - 30
- •Normal ovarian response (7 - 8 ovocitos) in IVF treatment with AFC ≥ 8, (AFC = Antral Follicle Count)
- •Elective embryo transfer
- •Normal uterine cavity
- •Age: ≤ 38 years old for patients with own oocytes; ≤ 50 years old for patients with donated oocytes.
排除标准
- •Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical miscarriage)
- •Patients with severe male factor ( ≥ 2*106 espermatozoides/ml).
结局指标
主要结局
endometrial receptivity
时间窗: 24 hours before embryo transfer
The endometrial samples will be extracted 24 hours before the embryo transfer in order to analyze the quantity of prostaglandins.
次要结局
- Implantation rate(15 days)
- Pregnancy rate(15 days)
研究者
研究点 (4)
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