To Study the Safety and Efficacy of A Novel Intrauterine Estrogen-Releasing System in Induced Abo… (NCT07381569) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
To Study the Safety and Efficacy of A Novel Intrauterine Estrogen-Releasing System in Induced Abortion
China200 participantsStarted 2026-03-01
Plain-language summary
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:
1. Can the estradiol-loaded silicone rubber intrauterine stent system increase the endometrial thickness at 21+2 days after the procedure?
2. 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:
1. 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
2. Attend scheduled follow-up visits at 21+2 days, after the first menstruation, and at 90 days post-procedure.
3. Undergo ultrasound examinations to measure endometrial thickness, and record vaginal bleeding duration, blood loss volume, time to first menstruation, and any adverse events
Who can participate
Age range18 Years – 40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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；