Endometrial and Isthmic Microbiota During IVF Stimulation in Patients Affected With Isthmocele and Intrauterine Mucus Secretion After C-section.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele.
研究概览
简要总结
To evaluate the endometrial and isthmic microbiota in patients with isthmocele after C-Section, and if this microbiota is similar or not with better reproductive outcomes.
详细描述
A total of 45 subjects undergoing in vitro fertilization treatment. Fifteen patients without isthmocele will be included in the control group and 30 patients affected with isthmocele in the other group, divided in 2 subgroups: 15 with 1 previous C-Section, and 15 with 2 or more previous C-Section. Paired samples of endometrial fluid (EF) and isthmic fluid (IF) will be obtained simultaneously the day of egg retrieval. Patients will follow a protocol for all-freezing embryos or oocytes.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with isthmocele:
- •Patients performing IVF treatment with a planned cycle segmentation and consecutive frozen embryo transfer on a hormone replacement therapy (HRT) cycle or natural cycle.
- •Age between 18 - 45 years all (both inclusive).
- •One or multiple C-sections.
- •Isthmocele present during TV scan.
- •BMI: 18,5 - 35 kg / m2 (both inclusive).
- •Patients without isthmocele:
- •Patients performing IVF treatment with planned cycle segmentation and who would have embryo transfer with frozen embryos under hormone replacement therapy.
- •NO Isthmocele present during transvaginal ultrasound.
- •BMI: 18,5 - 30 kg / m2 (both inclusive).
排除标准
- •Age < 18 and > 45 years old.
- •Previous or active endometritis.
- •Patients who are IUD carriers for the last 3 months.
- •Patients who have taken prescribed antibiotics in the last 3 months previous to sample collection.
结局指标
主要结局
If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele.
时间窗: 1year
patients undergoing in vitro fertilization treatment
次要结局
未报告次要终点
研究者
Prof Dr. Human Fatemi
Principal Investigator
ART Fertility Clinics LLC