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NCT Number: NCT07381569

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

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Key information

Conditions

Abortion, Induced

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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；
  • Patients with mental or cognitive impairment, unable to cooperate with the treatment process；
  • Patients considered by the investigator to have potential risks or factors making them unsuitable for inclusion.

Treatment and study plan

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.

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.

Primary outcomes

  1. Endometrial thickness

    Time frame: 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.

Secondary outcomes

  1. Vaginal bleeding volume

    Time frame: 14 days post-surgery

    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.

  2. Vaginal bleeding duration

    Time frame: 14 days post-surgery

    Assess the duration of vaginal bleeding after induced abortion surgery, measured in hours/days (recorded from the end of surgery until bleeding stops).

  3. Time to menstrual resumption after abortion

    Time frame: 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").

    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.

  4. Changes in menstrual blood volume at first menstrual period post-abortion

    Time frame: 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".

    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).

Other outcomes

  1. Abnormality rate of blood, biochemical, and hormonal indicators

    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.

    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).

  2. Positive rate of bacterial culture on intrauterine stent surface

    Time frame: After stent removal at 21±2 days after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xinyan Liu

CONTACT

[email protected]

+86 186 0000 8013

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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