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

NCT07381569 · tracked via the Priya Life Science China tracker

Sponsor

Peking Union Medical College Hospital

Phase

Not applicable

Started

2026-03-01

Last updated

2026-02-02

Condition(s) studied

Abortion, Induced

Investigational drug(s) / intervention(s)

Estradiol-Loaded Silicone Rubber Intrauterine Stent SystemNo-Drug-Loaded Silicone Rubber Intrauterine Stent System

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.

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.

Study 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

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

40 Years

Healthy volunteers

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.

Primary outcome measure(s)

Endometrial thickness — 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.

Trial sites (1)

Facility	City	Region	Status
Peking Union Medical College Hospital	Beijing	Dongcheng

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07381569 on ClinicalTrials.gov ↗ ← All trials in China