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

A Clinical Study on the Safety and Efficacy of Estradiol-Loaded Silicone Rubber Intrauterine Stent System for Promoting Endometrial Repair After Induced Abortion

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

Study Overview

• Status: Not yet recruiting
• Conditions: Abortion, Induced
• Intervention / Treatment: Device: Estradiol-Loaded Silicone Rubber Intrauterine Stent System; Device: No-Drug-Loaded Silicone Rubber Intrauterine Stent System

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xinyan Liu; Phone Number: +86 186 0000 8013; Email: liuxymeng@163.com

Study Locations

• China
  • Dongcheng
    • Beijing, Dongcheng, China, 100010
      • Peking Union Medical College Hospital
      • Contact: Xinyan Liu; Phone Number: 186 0000 8013; Email: liuxymeng@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Estradiol-Loaded Silicone Rubber Intrauterine Stent System	Device: Estradiol-Loaded Silicone Rubber Intrauterine Stent System; After abortion, an estradiol-loaded silicone rubber intrauterine stent system was placed for 21+2 days, and oral anti-infective medication was administered for 3 days postoperatively.
Sham Comparator: No-Drug-Loaded Silicone Rubber Intrauterine Stent System	Device: No-Drug-Loaded Silicone Rubber Intrauterine Stent System; After abortion, a no-drug-loaded silicone rubber intrauterine stent system was placed for 21+2 days, and oral anti-infective medication was administered for 3 days postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial thickness	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.	at 21 + 2 Days Postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal bleeding volume	Assessed by investigator-conducted follow-up interview at 14 days postoperatively. The postoperative vaginal bleeding volume is categorized as less, moderate, or more based on the subject's subjective perception, compared with her pre-operative menstrual flow volume.	14 days post-surgery
Vaginal bleeding duration	Assess the duration of vaginal bleeding after induced abortion surgery, measured in hours/days (recorded from the end of surgery until bleeding stops).	14 days post-surgery
Time to menstrual resumption after abortion	Time interval from the date of induced abortion surgery to the first day of spontaneous vaginal bleeding that meets the patient's usual menstrual flow volume and duration.	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	Compare the blood volume of the first menstrual period after abortion with the patient's pre-pregnancy usual menstrual blood volume (assessed via patient-reported sanitary product usage).	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".

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abnormality rate of blood, biochemical, and hormonal indicators	This outcome measures the proportion of participants with at least one abnormal indicator result. An indicator is defined as abnormal if its value falls outside the clinical normal reference range. The calculation formula is: (Number of participants with ≥1 abnormal result / Total eligible participants) × 100%. Included indicators cover routine blood tests, routine urine tests, coagulation function tests, routine vaginal discharge examination, liver function tests, kidney function tests, estradiol and progesterone levels (specific indicators tested differ by time frame).	Pre-surgery: All 8 abovementioned indicators are tested and included in the abnormality rate calculation. 21 ± 2 days post-surgery: Only liver function tests, kidney function tests, estradiol and progesterone levels are tested.
Positive rate of bacterial culture on intrauterine stent surface	This outcome measure assesses intrauterine stent-related infection risk by culturing the patient's fluid samples from the stent surface. The specific method is to gently wipe the stent surface with a sterile swab to collect the patient's fluid. The "positive rate of bacterial culture on intrauterine stent surface" refers to the proportion of stents with positive bacterial culture results.	After stent removal at 21±2 days after surgery

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: K8309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No