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

NCT07381569 | Not Yet Recruiting

• 1 other identifier: K8309
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.Can the estradiol-loaded silicone rubber intrauterine stent system increase the endometrial thickness at 21+2 days after the procedure?
2. 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.
3. 3.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
4. 4.Attend scheduled follow-up visits at 21+2 days, after the first menstruation, and at 90 days post-procedure.
5. 5.Undergo ultrasound examinations to measure endometrial thickness, and record vaginal bleeding duration, blood loss volume, time to first menstruation, and any adverse events

Conditions

Abortion, Induced

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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".

Other Outcomes (2)

• Abnormality rate of blood, biochemical, and hormonal indicators

  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

  After stent removal at 21±2 days after surgery

Study Arms (2)

Estradiol-Loaded Silicone Rubber Intrauterine Stent System

EXPERIMENTAL

Device: Estradiol-Loaded Silicone Rubber Intrauterine Stent System

No-Drug-Loaded Silicone Rubber Intrauterine Stent System

SHAM COMPARATOR

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

Interventions

Estradiol-Loaded Silicone Rubber Intrauterine Stent System DEVICE

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.

Estradiol-Loaded Silicone Rubber Intrauterine Stent System

No-Drug-Loaded Silicone Rubber Intrauterine Stent System DEVICE

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.

No-Drug-Loaded Silicone Rubber Intrauterine Stent System

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Dongcheng, 100010, China

Location

Central Study Contacts

Xinyan Liu

CONTACT

+86 186 0000 8013; liuxymeng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: February 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)