Microbiome and Endometrial Receptivity in Obese Infertile Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Microbiological analysis of endometrial fluid samples through massive sequencing
研究概览
简要总结
The objective of this project is the identification and quantification of the main bacterial communities present in the endometrial microbiota in obese infertile patients, to assess if there is an alteration of their composition dependent on the body mass index, and if such alteration it could influence the reduction of endometrial receptivity, demonstrated in obese women. If obese patients have an altered digestive microbiota and, at the same time, a lower endometrial receptivity, the investigator want to assess whether such reduction in receptivity may depend on an alteration in the endometrial microbiota, which in non-obese infertile patients has been shown to negatively influence the reproductive results
详细描述
The main objective of our study is to compare the composition of the endometrial microbiota between patients with normal weight and patients with obesity.
A. Secondary Objectives/research questions
- To analyze the composition of the digestive microbiota through samples of saliva and feces in infertile patients with normal weight and obesity.
- To assess whether there is a relationship between the body mass index (normal weight, obesity Class I, Class II, Class III) and the main bacterial species detected in endometrial fluid samples from infertile patients.
- To evaluate the influence of the digestive microbiota on the composition of the endometrial microbiota according to the body mass index in infertile patients.
- To evaluate if there is an influence of the endometrial microbiota on the results of endometrial receptivity analyzed with the non-invasive Endometrial Receptivity Array test (niERA)
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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile patients undergoing artificial cycle with HRT.
- •Normal uterus confirmed by ultrasound (absence of uterine pathology such as submucosal or intramural myomas> 4 cm that deform cavity, endometrial polyps or Müllerian anomalies, or adnexal as communicating hydrosalpinx).
- •Negative serological tests for HIV, HBV, HCV, RPR
排除标准
- •Taking prescribed antibiotics or using IUDs or contraceptives 3 months prior to taking the sample. NOTE: Patients who have taken prophylactic antibiotics for ovarian puncture may be included at least 1 month before taking the sample.
- •Age> 45 years
- •Uncorrected uterine pathology, uncorrected hydrosalpinx
- •Recurrent miscarriage (≥2 spontaneous abortions) or failure of implantation (transfer of 6 embryos in day 3 or 4 blastocysts in a cycle of IVF or donation of oocytes without gestation)
- •Existence of serious or uncontrolled bacterial, fungal or viral infections that, in the opinion of the principal investigator, could interfere with the participation of the patient in the study or in the evaluation of the results of the study.
- •Any disease or medical condition that is unstable or could endanger the patient's safety and compliance in the study.
结局指标
主要结局
Microbiological analysis of endometrial fluid samples through massive sequencing
时间窗: 14 months
Identification and quantification of the main bacterial communities present in the endometrial microbiota of obese and normal-weight infertile patients through the analysis of the endometrial fluid.
次要结局
- Analysis of endometrial receptivity using niERA(13 months)
- Microbiological analysis of saliva samples through massive sequencing.(14 months)
- Microbiological analysis of feces samples through massive sequencing.(14 months)