Incidence of Not Receptive Endometrium During the Window of Implantation as Body Mass Index by Testing ERA.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 3
- 主要终点
- Non Receptive Endometrium
研究概览
简要总结
This study evaluates the incidence of Non Receptive endometrium in obese infertile women compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test, containing 238 genes, identifying the receptivity status of an endometrial sample and diagnosing the patient's Window of Implantation, regardless of the histological appearance of the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women: > 1 year of regular unprotected intercourse without evidence of pregnancy.
- •Normal uterus by 2D/3D ultrasound scan and/or hysteroscopy
- •No endometriosis
- •Presence of both ovaries
- •< 45 years old (in ovum donation, outcome parameters are not affected until this age in all the current published studies).
排除标准
- •Hydrosalpinx
- •Stage 3-4 endometriosis diagnosed with ultrasound, laparoscopy/ laparotomy.
- •Implantation failure (≥ 4 pre-embryos of good quality transferred without pregnancy)
- •Recurrent pregnancy loss (≥ 2 pregnancies biochemical / clinical)
研究组 & 干预措施
Group B
Obese patients
干预措施: Endometrial Receptivity Array analysis of endometrial biopsy (Other)
Group A
Non Obese patients
干预措施: Endometrial Receptivity Array analysis of endometrial biopsy (Other)
结局指标
主要结局
Non Receptive Endometrium
时间窗: 25 days
To evaluate the incidence of Not Receptive endometrium in obese infertile women compared to infertile normal weight women using an adequate sample size.
次要结局
- Look for specific endometrial gene patterns.(25 days)
- Distribution of fat and risk factors(4 months)
- Evaluate the result of assisted reproduction treatment.(12 months)
研究者
Jose Bellver
Dr. Jose Bellver
Instituto Valenciano de Infertilidad, IVI VALENCIA