Reproductive Tract Microbiome in Women With Recurrent Pregnancy Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Midluteal bacterial composition of endometrium in women with recurrent pregnancy loss and control group
研究概览
简要总结
The female genital tract microbiome may reflect female reproductive health and may be related to pregnancy outcomes. Disturbances in this microbiome may be associated with adverse reproductive outcomes. The investigators hypothesize that the endometrial and vaginal microbiome composition in women with a history of recurrent pregnancy loss are different, compared with those in normal fertile women.
详细描述
The investigators want to describe the endometrial microbiome composition in normal fertile women and women with a history of recurrent pregnancy loss by analyzing mid-luteal phase vaginal swab and endometrial biopsy samples using 16S rRNA sequencing.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-38 years old
- •Having a regular menstrual cycle, from 25 to 35 days
- •Having ≥ 2 recurrent pregnancy loss and
- •Couples with normal karyotype results
- •Having no condition causing pregnancy loss such as antiphospholipid syndrome, abnormal thyroid function.
- •Agree to participate in the study
排除标准
- •Irregular menstrual cycle
- •Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal fibroid)
- •Using intrauterine device within the last 3 months
- •Using antibiotic/vaginal pessary/contraceptive pills within 2 weeks
- •Having sexual intercourse within 48 hours
- •Healthy control patients
- •Inclusion Criteria:
- •18-38 years old
- •Having a regular menstrual cycle, from 25 to 35 days
- •No history of pregnancy loss
- •Having 1 or more live birth, with the youngest child ≥ 6 months old
- •Agree to participate in the study
- •Exclusion Criteria:
- •Irregular menstrual cycle
- •Having uterine abnormalities (e.g., adenomyosis, intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal fibroid)
- •Using intrauterine device within the last 3 months
- •Using antibiotic/vaginal pessary/contraceptive pills within 2 weeks
- •Having sexual intercourse within 48 hours
结局指标
主要结局
Midluteal bacterial composition of endometrium in women with recurrent pregnancy loss and control group
时间窗: 1 week
Bacterial composition in the endometrium in midluteal phase are analysed using 16S rRNA gene sequencing
次要结局
- Phylogenetic tree of endometrial microorganisms in women with recurrent pregnancy loss and control group(1 week)
- Phylogenetic tree of vaginal microorganisms in women with recurrent pregnancy loss and control group(1 week)
- Midluteal bacterial composition of vagina in women with recurrent pregnancy loss and control group(1 week)