A Randomised Controlled Trial of Hysteroscopic Resection of Mild Septum/Arcuate Uteri in Women With Recurrent Miscarriage.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The spontaneous abortion rate of the two groups
研究概览
简要总结
At least 82 cases of recurrent miscarriage women with a diagnosis of arcuate uterus, confirmed by three-dimensional intra-vaginal sonography (3D-TVS) and hysteroscopy, will be recruited. The subjects will be randomly divided into two groups, the experimental group will be given hysteroscopic treatment, the control group will receive no treatment. The pregnancy rates (>12 weeks) of the two groups will befollowed and compared.
详细描述
This study will be carried out at the Hysteroscopy center of the Fuxing Hospital, Beijing, China. At least 82 recurrent miscarriage women with a diagnosis of arcuate uterus who had unexplained recurrent spontaneous abortion (less than 12 weeks) before and have fertility requirement will be recruited. The patients will be explained the study and sign the informed consent. According to the random number table, the corresponding cases were divided into treatment group and control group. The experimental group will be given hysteroscopic treatment, the control group will receive no treatment. The follow up of the spontaneous abortion rate and the pregnancy rate of two groups will be screened within 1-2 years and the correlation between the arcuate uterus and recurrent miscarriage will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with arcuate/mild septum uteri
- •Women with unexplained recurrent miscarriage (less than 12 weeks)
- •Having a second time fertility requirement
- •Having Informed consent before entering this study, and be willing to receive hysteroscopic treatment
排除标准
- •3D-TVS and hysteroscopy suggest uterine fibroids (submucosal and III type uterine fibroids, intramural fibroids,the diameter of whichis greater than 4cm), adenomyosis, endometrial polyps, intrauterine adhesions and other uterine factors that may lead to spontaneous abortion
- •Endometrial pathological diagnosis of chronic endometritis, endometrial hyperplasia and endometrial cancer
- •Ultrasound or HSG suggest hydrosalpinx
- •Chromosome abnormalities of the couples, positive findings of pre-thrombosis state and the detection of immunity, uterine malformation, uterine fibroids, adenomyosis and other uterine factors causing recurrent miscarriage
- •Semen abnormality in male
结局指标
主要结局
The spontaneous abortion rate of the two groups
时间窗: 2 years
The spontaneous abortion rate of the two groups after receiving hysteroscopic treatment and no treatment.
The live birth rate of the two groups
时间窗: 2 years
Te live birth rate of the two groups after receiving hysteroscopic treatment and no treatment.
The pregnancy rate(>12 weeks)of the two groups
时间窗: 2 years
The pregnancy rate(\>12 weeks) of the two groups after receiving hysteroscopic treatment and no treatment.
次要结局
未报告次要终点
研究者
Song Dongmei
Principal Investigator
Fu Xing Hospital, Capital Medical University