A Prospective Case-control Study of the Outcome and Influence Factors of Assisted Reproductive Therapy in Patients With Cesarean Scar Uterus.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Species and communities of uterine microflora
研究概览
简要总结
Mode of delivery affects the success rate of assisted reproductive techniques (ART). In this case study, the investigators will evaluate changes in the bacterial ecology and inflammatory markers of the female uterus with different delivery modes. We will investigate whether the dominate endometrial microflora is interrupted by the Cesarean section in the infertile women undergoing ART, and the potential mechanism will also be further explored prospectively.
详细描述
The highly prevalence of cesarean section rate in China had drawn great attention world widely. Post-cesarean section scar diverticulum ( PCSD) is a poor healing of the local incision after Cesarean section which happened in19.4%~88% of patients. The cavity is formed by the original incision connected with the uterine cavity. Patients with diverticulum are often accompanied by prolonged menstruation and uterine effusion, which may accompany with endometrial inflammation and impair embryo implantation rate.
Though Cesarean section plays an important role in the treatment of dystocia and also decreasing perinatal mortality, it may impact natural conception and the success rate of ART in secondary infertile patients. Data from other researchers have revealed that Cesarean scar may related to poor pregnancy outcome during ART treatment. We have retrospectively analyzed the pregnancy outcome of ART treatment in patients who have had live birth previously from January 2014 to May 2018. The biochemical pregnancy rate, embryo implantation rate and clinical pregnancy rate are all lower in patients with Caesarean section compared to patients after natural labour, the clinical data is even worse in patients with PCSD. The results suggest a close correlation between the outcome of assisted reproductive therapy and the uterine condition. Further evaluations are required related to whether the dominate endometrial microflora is interrupted by the Cesarean section in the infertile women undergoing ART, and the potential mechanism will also be explored accordingly. A single-center, prospective, case-control study will be carried out.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age ≥20 years and ≤40 years.
- •infertile Women with previously live birth.
- •Previous failed transfer cycle ≤2
- •Didn't participate in other clinical subjects within three months.
- •Written informed consent.
排除标准
- •surgery history including: Ovariectomy, myomectomy, adenomyomectomy.
- •Uterine diseases including: uterine malformation, submucosal uterine fibroids and intrauterine adhesion.
- •One of couple has abnormal karyotype.
- •Recurrent abortion ≥
- •Untreated hydrosalpinx.
- •History of tuberculosis (pulmonary tuberculosis, pelvic tuberculosis etc.).
结局指标
主要结局
Species and communities of uterine microflora
时间窗: 1-2 year
Use the swab to scrape endometrium. Characterization of species and communities of uterine microflora will use bacterial DNA microarray analysis. Normally, the uterine cavity used to being thought a sterile space.
Inflammatory markers of the female uterus
时间窗: 1-2 year
Use the swab to scrape endometrium. Characterization of inflammatory markers of the female uterus will use human cytokines measuring. The cytokines will include IL2,IL4,SDF-1α , etc. Use the natural labor group as control group, and see differentiation among the three group.
次要结局
- Live birth rate(1-2 year)
- Embryo implantation rate(1-2 year)
- Clinical pregnancy rate(1-2 year)
- Biochemical pregnancy rate(1-2 year)
研究者
Yanhong Deng
MD
Sun Yat-sen University