NCT07381569尚未招募不适用
A Clinical Study on the Safety and Efficacy of Estradiol-Loaded Silicone Rubber Intrauterine Stent System for Promoting Endometrial Repair After Induced Abortion
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Endometrial thickness
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and efficacy of the estradiol-loaded silicone rubber intrauterine stent system for promoting endometrial repair after artificial abortion. The main research questions it aims to answer are:
- Can the estradiol-loaded silicone rubber intrauterine stent system increase the endometrial thickness at 21+2 days after the procedure?
- What adverse events or safety issues occur in participants when using this product? Researchers will compare the estradiol-loaded silicone rubber intrauterine stent system with a non-drug-loaded silicone intrauterine stent to determine whether the drug-eluting stent offers advantages in promoting endometrial repair.
Participants will:
- Undergo placement of either the estradiol-eluting stent or the non-drug stent immediately after artificial abortion, with the stent retained for 21+2 days
- Attend scheduled follow-up visits at 21+2 days, after the first menstruation, and at 90 days post-procedure.
- Undergo ultrasound examinations to measure endometrial thickness, and record vaginal bleeding duration, blood loss volume, time to first menstruation, and any adverse events
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-40 years；
- •Menstrual cycle was 21-35 days within the six months before enrollment；
- •BMI between 18.5-28 kg/m²；
- •Voluntary termination of pregnancy, history of ≥2 abortions or missed abortion, and confirmed gestational age ≤10 weeks；
- •Willing to participate, able to attend regular follow-ups, and sign the informed consent form.
排除标准
- •Known allergy or contraindication to silicone rubber or estrogen；
- •History of hysteroscopically confirmed uterine adhesions or diagnosed thin endometrium；
- •Uterine malformation, uterine fibroids compressing the uterine cavity, or other causes of abnormal uterine cavity shape；
- •Participants requesting IUD placement, oral contraceptives, or subcutaneous implantation after surgery；
- •Patients with mental or cognitive impairment, unable to cooperate with the treatment process；
- •Patients considered by the investigator to have potential risks or factors making them unsuitable for inclusion.
研究组 & 干预措施
Estradiol-Loaded Silicone Rubber Intrauterine Stent System
Experimental
干预措施: Estradiol-Loaded Silicone Rubber Intrauterine Stent System (Device)
No-Drug-Loaded Silicone Rubber Intrauterine Stent System
Sham Comparator
干预措施: No-Drug-Loaded Silicone Rubber Intrauterine Stent System (Device)
结局指标
主要结局
Endometrial thickness
时间窗: at 21 + 2 Days Postoperatively
Measured via transvaginal ultrasound (unit: mm). The measurement is defined as the maximum perpendicular distance between the interface of the myometrium and endometrium on the anterior and posterior walls of the uterine cavity, obtained from the largest sagittal section of the uterus.
次要结局
- Vaginal bleeding volume(14 days post-surgery)
- Vaginal bleeding duration(14 days post-surgery)
- Time to menstrual resumption after abortion(Followed up and recorded within 60 days after induced abortion surgery (if no menstruation occurs by day 60, it will be recorded as "no resumption within 60 days").)
- Changes in menstrual blood volume at first menstrual period post-abortion(Assessed at the end of the first menstrual period after abortion, with follow-up and recording completed within 60 days post-abortion.If no menstruation occurs by day 60, it will be recorded as "no resumption within 60 days".)
研究者
研究点 (1)
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