Abortion, InducedNCT07381569
To Study the Safety and Efficacy of A Novel Intrauterine Estrogen-Releasing System in Induced Abortion
A study testing Estradiol-Loaded Silicone Rubber Intrauterine Stent System and No-Drug-Loaded Silicone Rubber Intrauterine Stent System in people with Abortion, Induced, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Abortion, Induced
- What is being tested?
- Estradiol-Loaded Silicone Rubber Intrauterine Stent System and No-Drug-Loaded Silicone Rubber Intrauterine Stent System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Dongcheng, 100010
Xinyan Liu, 186 0000 8013, liuxymeng@163.com
About this study
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
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:
- Can the estradiol-loaded silicone rubber intrauterine stent system increase the endometrial thickness at 21+2 days after the procedure?
- 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.
Read more
Participants will:
- 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
- Attend scheduled follow-up visits at 21+2 days, after the first menstruation, and at 90 days post-procedure.
- 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
- Being tested
- Estradiol-Loaded Silicone Rubber Intrauterine Stent System, No-Drug-Loaded Silicone Rubber Intrauterine Stent System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol-Loaded Silicone Rubber Intrauterine Stent SystemDevice
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 SystemDevice
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 group | Role | What they receive |
|---|---|---|
| Estradiol-Loaded Silicone Rubber Intrauterine Stent System | Experimental | Not described Receives: Device: Estradiol-Loaded Silicone Rubber Intrauterine Stent System |
| No-Drug-Loaded Silicone Rubber Intrauterine Stent System | Sham comparator | Not described Receives: Device: No-Drug-Loaded Silicone Rubber Intrauterine Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 21 + 2 Days Postoperatively
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion, InducedStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381569
- Sponsor's protocol ID
- K8309
- Status last verified
- Sep 2025
- First submitted
- 27 Nov 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07381569
- Acronym / sponsor ID
- K8309
- Conditions
- Abortion, Induced
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can the estradiol-loaded silicone rubber intrauterine stent system increase the endometrial thickness at 21+2 days after the procedure?
- 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:
- 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
- Attend scheduled follow-up visits at 21+2 days, after the first menstruation, and at 90 days post-procedure.
- Undergo ultrasound examinations to measure endometrial thickness, and record vaginal bleeding duration, blood loss volume, time to first menstruation, and any adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol-Loaded Silicone Rubber Intrauterine Stent SystemAfter 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 | Estradiol-Loaded Silicone Rubber Intrauterine Stent System |
| No-Drug-Loaded Silicone Rubber Intrauterine Stent SystemAfter 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. | Device | No-Drug-Loaded Silicone Rubber Intrauterine Stent System |
Primary outcome
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.
4 secondary outcomes
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".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estradiol-Loaded Silicone Rubber Intrauterine Stent System and No-Drug-Loaded Silicone Rubber Intrauterine Stent System in people with Abortion, Induced, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyan Liu (+86 186 0000 8013, liuxymeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial thickness (time frame: at 21 + 2 Days Postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.