A Protocol for a Prospective Study to Compare the Endometrial Microbiome in Patients With Body Mass Index Over 30 kg/m² Versus Under 25 kg/m².
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Microbiome variety between groups
研究概览
简要总结
This study project is an observational trial involving 90 patients suffering from male type infertility. The patients are divided in two groups (45 patients per group) based on their body mass index (BMI).
详细描述
This study (Tampere Infertility Microbiome Project, TIMP) aims to clarify the differences in the microbiome variety between obese and normal-weight patients. The first group will consist of patients with the body mass index (BMI) over 30 kg/m², while the second group will include patients with a healthy weight BMI under 25. The samples will be collected at the time of embryo transfer and analyzed in a laboratory specialing in next-generation sequencing (NGS) techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with male infertility scheduled for IVF treatment and fresh embryo transfer
- •Primary or secondary male-type infertility
- •BMI over 30 kg/m² or under 25 kg/m²
- •Patient's willingness to participate
排除标准
- •Patients with endometriosis or adenomyosis
- •Use of antibiotics during IVF treatment or oocyte retrieval
- •Technical diffuculties in embryo transfer or no embryos available for transfer
结局指标
主要结局
Microbiome variety between groups
时间窗: through study completion, 1-2 years from the starting date
This study aims to investigate differences of endometrium microbiome and continuum of microbiota from anal to reproductive tract site between obese and normal-weight patients. Samples will be collected at the time of embryo transfer using embryo transfer catheter. The study will also examine pregnancy outcomes and microbiome differences in pregnant patients.
次要结局
- Ongoing pregnancy rate(up to 2-3 months)