A Prospective, Randomized,Controlled Trial on the Effect of Antibiotic Therapy on Endometrial Response in Women With Chronic Endometritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The Conversion Rate of CE (From Positive to Negative)
研究概览
简要总结
120 cases with a diagnosis of chronic endometritis, confirmed by the presence of plasma cells in endometrial biopsy sample identified by immunohistochemical staining using CD138 antibody, have been recruited. The subjects have been randomly divided into two groups, the experimental group have been given antibiotic (Levofloxacin and Tinidazole for 14 days) treatment, the control group did not receive any antibiotic. Initially it was planned for women in the control group to take placebo,but the organization was difficult, so it was changed prior to the start of the study to an open label study. A repeat endometrial biopsy sample have been obtained 2-4 weeks after completion of the antibiotic therapy to assess the response to treatment. The conversion rate will be compared between the two groups
详细描述
This study will be carried out at the Hysteroscopy centre of the Fuxing Hospital, Capital Medical University ,Beijing, China. A total of 120 women with chronic endometritis who fulfilled the following inclusion criteria will be recruited:
- CD138 immunohistochemical staining of endometrial specimen showed presence of one or more plasma cells per 10HPF which confirmed chronic endometritis, according to published criteria.
- women who were pre-menopausal.
- no evidence of endometrial hyperplasia or malignancy or structural uterine pathology.
- agreement to have a second endometrial biopsy ~4 weeks after the initial endometrial biopsy.
- written informed consent obtained
Exclusion Criteria:
- women who received steroid hormone therapy within one month of recruitment.
- allergy or suspected allergy to the chosen antibiotic therapy.
- women who developed any concurrent infection and received any antibiotic therapy during the period of study other than the one prescribed according to the study protocol.
Power calculation: Assuming that the spontaneous CD138 conversion (from positive to negative ) rate is 25% and that the antibiotic therapy results in 60% conversion rate, the total number of subjects required in each arm of the RCT will be 37, accepting a Type I error of 0.05 and a Type II error of 0.1, and assuming a drop-out rate of 20%, 45 subjects will need to be recruited into each arm. Hence, a total of 90 subjects who fulfilled the inclusion criteria will be required.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •CD138 immunohistochemical staining of endometrial specimen showed presence of one or more plasma cells per 10HPF which confirmed chronic endometritis, according to published criteria.
- •women who were pre-menopausal.
- •no evidence of endometrial hyperplasia or malignancy or structural uterine pathology.
- •agreement to have a second endometrial biopsy ~4 weeks after the initial endometrial biopsy.
- •written informed consent obtained
排除标准
- •women who received steroid hormone therapy within one month of recruitment.
- •allergy or suspected allergy to the chosen antibiotic therapy.
- •women who developed any concurrent infection and received any antibiotic therapy during the period of study other than the one prescribed according to the study protocol.
研究组 & 干预措施
Antibiotic group
This group received antibiotic therapy
干预措施: Antibiotics (Drug)
结局指标
主要结局
The Conversion Rate of CE (From Positive to Negative)
时间窗: 1-6 months
Subjects in antibiotic group underwent a second-look hysteroscopy and repeat endometrial biopsy for histopathological CD138 immunohistochemical examination 2-4 weeks after completion of antibiotic treatment and in the follicular phase of the following menstrual cycle. Subjects in control group underwent a second-look hysteroscopy and repeat endometrial biopsy for histopathological CD138 immunohistochemical examination \~4 weeks after recruitment in the follicular phase of the following menstrual cycle. The biopsies were graded as "negative" for CE if there was less than one plasma cell identified per 10 high-power fields (HPFs) and "positive" when there was one or more plasma cell identified per 10 HPFs. To compare the cure rate (From positive to negative) of CE in women who received antibiotic therapy (treatment group) with the spontaneous cure rate in those who did not receive antibiotic therapy (control group),
次要结局
未报告次要终点
研究者
Song Dongmei
Hysteroscopy Center
Fu Xing Hospital, Capital Medical University