NCT07488949招募中不适用
Clinical Efficacy and Pregnancy Outcomes of Doxycycline Combined With Medroxyprogesterone Acetate Therapy for Chronic Endometritis(CE) in Patients With Recurrent Reproductive Failure(RRF): A Prospective Randomized Controlled Trial
Fang Wang1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年4月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Cure rate of chronic endometritis
研究概览
简要总结
A Prospective Randomized Controlled Trial, the goal of this clinical trial is to evaluate the efficacy and safety of doxycycline alone versus doxycycline plus medroxyprogesterone acetate (MPA) in women with chronic endometritis (CE), and to assess subsequent reproductive outcomes. Participants will be randomly assigned to one of two groups and will receive the assigned treatment. Participants will be followed for reproductive outcomes, including pregnancy , ongoing pregnancy, spontaneous miscarriage, and live birth.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 20-45 years;
- •plans to conceive within 12 months;
- •chronic endometritis(CE) confirmed by endometrial CD138 immunohistochemistry (IHC);
- •a diagnosis of recurrent reproductive failure(RRF);
- •willingness to undergo hysteroscopy and endometrial biopsy;
- •no contraindications to the study medications.
排除标准
- •acute genital tract infection, gynecologic malignancy, endometrial hyperplasia, or uterine fibroids;
- •pregnancy or lactation;
- •contraindications to hysteroscopy or anesthesia;
- •use of antibiotics, glucocorticoids, estrogens, or progestins within 3 months before trial initiation;
- •allergy to doxycycline or medroxyprogesterone acetate(MPA);
- •abnormal semen parameters in the male partner.
结局指标
主要结局
Cure rate of chronic endometritis
时间窗: At 8 weeks after completion of treatment
次要结局
- pregnancy rate(From completion of treatment to the end of the follow-up period, with a minimum follow-up of 6 months.)
- Live birth rate(From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months)
- Rate of pregnancy loss(From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months)
- sustained pregnancy rate(From completion of treatment to the end of follow-up, with a minimum follow-up of 6 months)
研究者
Fang Wang
Chief physician
Lanzhou University Second Hospital
研究点 (1)
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