The Microbiome in Subfertility and Assisted Reproductive Technologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Clinical pregnancy
研究概览
简要总结
To assess the impact of the female genital microbiome on ART outcome.
详细描述
The main objective of this study is to learn more about which microbial spectra are negatively or positively impacting IVF pregnancy outcome. This information is needed before proceeding to the next step in which an adaptation of the microbiome can be attempted to improve IVF outcome. The study is expected to shed light over the possible influence of the microbiome on causes for subfertility, endometrial receptivity and obstetrical complications. A diagnostic link may be found with entities that are often unexplained today, e.g. (recurrent) miscarriage and repeated implantation failure.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Caucasian women
- •Women undergoing an in-vitro fertilization cycle (for the first or second time)
- •Single embryo transfer
- •Day 5 embryo transfer
- •Gonadotropin-releasing hormone antagonist
- •Anti-mullerian hormone > 0,69 and < 3,5 µg/L
- •Body mass index ≤ 30 kg/m2
- •Signed informed consent
排除标准
- •Women suffering of chronic diseases which may impair pregnancy outcome (e.g. diabetes, chronic renal disease).
- •Antibiotics within 3 weeks of sampling
- •Surgical sperm retrieval
- •In-vitro maturation
- •Preimplantation genetic diagnosis
- •Grade 3 or 4 endometriosis
- •Patients unable to comprehend the investigational nature of the proposed study
结局指标
主要结局
Clinical pregnancy
时间窗: 7 weeks
To determine if there Is there a association between the microbiome profile and pregnancy outcome after ART
次要结局
- Baseline microbiome profile(1 week)
- Variation of microbiome profile during assisted reproductive technologies(5 weeks)
- Microbiome profile of the embryo culture(1 week)
- Live birth(43 weeks)
研究者
Blockeel Christophe
MD, PhD
Universitair Ziekenhuis Brussel