To Study the Safety and Efficacy of A Novel Intrauterine Estrogen-Releasing System in Induced Abortion

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Begins enrollment this month

Conditions: Abortion, Induced

Treatments: Device: Estradiol-Loaded Silicone Rubber Intrauterine Stent System; Device: No-Drug-Loaded Silicone Rubber Intrauterine Stent System

Study type: Interventional

Funder types: Other

Identifiers

NCT07381569

K8309

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Female patients aged 18-40 years；
2. Menstrual cycle was 21-35 days within the six months before enrollment；
3. BMI between 18.5-28 kg/m²；
4. Voluntary termination of pregnancy, history of ≥2 abortions or missed abortion, and confirmed gestational age ≤10 weeks；
5. Willing to participate, able to attend regular follow-ups, and sign the informed consent form.

Exclusion Criteria

1. Known allergy or contraindication to silicone rubber or estrogen；
2. History of hysteroscopically confirmed uterine adhesions or diagnosed thin endometrium；
3. Uterine malformation, uterine fibroids compressing the uterine cavity, or other causes of abnormal uterine cavity shape；
4. Participants requesting IUD placement, oral contraceptives, or subcutaneous implantation after surgery；
5. Patients with mental or cognitive impairment, unable to cooperate with the treatment process；
6. Patients considered by the investigator to have potential risks or factors making them unsuitable for inclusion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

200 participants in 2 patient groups

Estradiol-Loaded Silicone Rubber Intrauterine Stent System

Experimental group

Treatment:

Device: Estradiol-Loaded Silicone Rubber Intrauterine Stent System

No-Drug-Loaded Silicone Rubber Intrauterine Stent System

Sham Comparator group

Treatment:

Device: No-Drug-Loaded Silicone Rubber Intrauterine Stent System