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Not yet recruiting NCT07381569

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

No phase Interventional Abortion, Induced

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Estradiol-Loaded Silicone Rubber Intrauterine Stent System, No-Drug-Loaded Silicone Rubber Intrauterine Stent System.
Who it may be relevant to
Registry conditions: Abortion, Induced. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Endometrial thickness [Time frame: at 21 + 2 Days Postoperatively]
Secondary outcome measures (4)
  • Vaginal bleeding volume [Time frame: 14 days post-surgery]
  • Vaginal bleeding duration [Time frame: 14 days post-surgery]
  • 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").]
  • 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".]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07381569 · K8309

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗