Intrauterine AdhesionNCT04972032
Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis
A study testing Estrogen Intrauterine Stent System and Foley balloon combined with self-cross-link sodium hyaluronate gel in people with Intrauterine Adhesion, run by Limin Feng at 1 site in China.
Trial summary
This is a prospective, randomized, single-blinded,multi-center trial to compare the efficacy of an Estrogen-intrauterine stent system with foley balloon combined with intrauterine cross-linked sodium hyaluronate gel in the prevention of intrauterine adhsion recurrence after hysteroscopic adhesiolysis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Estrogen Intrauterine Stent System and Foley balloon combined with self-cross-link sodium hyaluronate gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2020to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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;
- Meets the diagnostic criteria for moderate to severe uterine adhesions;
- Has the indication for TCRA surgery and is intending to undergo TCRA surgery;
- Female subjects are not breastfeeding at the time of the screening visit; ⑤ Voluntary acceptance of the treatment and has signed the informed consent form.
Who cannot join
- Known allergic reactions to or contraindications for silicone rubber materials, estradiol and its metabolites, Foley balloon catheters and/or intrauterine cross-linked sodium hyaluronate gel;
- Presence of contraindications for TCRA surgery;
- Requires oral hormonal medications for a prolonged period of time;
- Has used high-dose estrogen medication within one month prior to surgery;
- Suffering from diseases such as genital tract tuberculosis, acute genital tract inflammation, pelvic inflammatory disease, abnormal uterine bleeding caused by systemic disease or malignant tumours of the genital organs; ⑥ Perimenopausal and menopausal females;
- ⑦ Comorbid with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal or hematopoietic system, or peptic ulcer disease, or severe diseases affecting patient survival (such as tumours or AIDS), or mental illness;
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- ⑧ Drug or alcohol dependence;
- ⑨ Has enrolled in other clinical trials within the last 1 month;
- ⑩ Patients with factors considered by the investigators to be unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
YiPuRun (Shanghai) Biotechnology Co.,Ltd.
Shanghai, Shanghai Municipality
Jing Lu, +8613482201715, jlu@puyibio.com
About this study
Official title: Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System
This is a prospective, randomized, single-blinded,multi-center trial to compare the efficacy of an Estrogen-intrauterine stent system with foley balloon combined with intrauterine cross-linked sodium hyaluronate gel in the prevention of intrauterine adhsion recurrence after hysteroscopic adhesiolysis.
Read the detailed description
Patients suspect to be suffering from IUA will be recruited following a systematic pre-operative assessment process. This will include a detailed history of the menstrual pattern, previous intrauterine surgery, and reproductive history, as well as 3D transvaginal ultrasound. The severity and extent of intrauterine adhesions will be scored according to the AFS score. All patients will receive hysteroscopic adhesiolysis with the aid of ultrasound guidance as necessary. After adhesiolyis, the patients will assigned to two groups randomly,namely,the E-IUS(estrogen intrauterine stent system) group and the control group. Adhesion will be evaluated by hysteroscopy at second-look hysteroscopy before 60 after surgery.
- Conditions
- Intrauterine Adhesion
- Being tested
- Estrogen Intrauterine Stent System, Foley balloon combined with self-cross-link sodium hyaluronate gel
- Keywords
- Intrauterine adhesion, recurrence, estrogen, intrauterine stent
- Medical subject headings
- Gynatresia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estrogen Intrauterine Stent SystemDevice
A Estrogen Intrauterine Stent System（E-IUS）will be introduced post-operatively. The E-IUS will be removed 60 days after surgery with continuous dydrogesterone administration for 5 days at 20 mg/d, and routine management.
Foley balloon combined with self-cross-link sodium hyaluronate gelDevice
Foley balloon combined with self-crosslinking sodium hyaluronate gel will be introduced post-operatively，2 cycles of estrogen-progestin sequential therapy comprised of continuous estrogen and progestin added in the second half of the cycle or continuous estradiol valerate for 60 days, followed by dydrogesterone for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Estrogen Intrauterine Stent System | Experimental | An Intrauterine Stent System with estrogen will be introduced into the uterine cavity after TCRA(transcervical resection of adheison). Receives: Device: Estrogen Intrauterine Stent System |
| Foley balloon combined with self-cross-link sodium hyaluronate gel | Other | Subjects will be given Foley balloon (manufacturer: Zhanjiang Star Enterprise Co., Ltd.) combined with self-cross-linked sodium hyaluronate gel (manufacturer: BioRegen Biomedical (Changzhou) Co., Ltd.) after TCRA surgery. Receives: Device: Foley balloon combined with self-cross-link sodium hyaluronate gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative adhesion recurrence rate(%)
The severity of adhesion will be assessed by hysteroscopy before and on d60 after surgery using the America Fertility Score (AFS) system. If the AFS score on D60 second-look hysteroscopy over 0 will be considered as adhesion recurrence. Post-operative adhesion recurrence rate(%)=(patients whose AFS score >0-point after surgery/All patients after surgery)X100%. The recurrence rate (%) is range from 0(Mini) to 100(Max).The lower the recurrence means the patient has a better post-operative outcome.
Measured: 60 days
Secondary outcomes (2)
Menstrual improvement rate %(PBAC score)
Menstrual improvement rate (evaluated by PBAC score) on 60 days after surgery
Measured: 60 days
Pregnancy rate%
Pregnancy rate%=Number of patients with successful Pregnancy /Number of all patients）X100%
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start2 Sep 2020
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limin Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Limin Feng, Beijing Tiantan Hospital
- Investigators
- Limin Feng, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972032
- Sponsor's protocol ID
- E-IUS
- Status last verified
- Sep 2021
- First submitted
- 30 Jun 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feng L, Sun Y, Zhang S, Qian Y, Fang S, Yang B, Xu L, Li J, Niu Y, Zhang S, Zhang L, Chen J. A novel intrauterine estrogen-releasing system for preventing the postoperative recurrence of intrauterine adhesion: a multicenter randomized controlled study. BMC Med. 2024 Sep 16;22(1):395. doi: 10.1186/s12916-024-03608-4.
PubMed 39285313
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System
- ClinicalTrials.gov ID
- NCT04972032
- Acronym / sponsor ID
- E-IUS
- Conditions
- Intrauterine Adhesion
- Keywords
- Intrauterine adhesion, recurrence, estrogen, intrauterine stent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Limin FengUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Jul 2021 (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.
This is a prospective, randomized, single-blinded,multi-center trial to compare the efficacy of an Estrogen-intrauterine stent system with foley balloon combined with intrauterine cross-linked sodium hyaluronate gel in the prevention of intrauterine adhsion recurrence after hysteroscopic adhesiolysis.
Detailed description
Patients suspect to be suffering from IUA will be recruited following a systematic pre-operative assessment process. This will include a detailed history of the menstrual pattern, previous intrauterine surgery, and reproductive history, as well as 3D transvaginal ultrasound. The severity and extent of intrauterine adhesions will be scored according to the AFS score. All patients will receive hysteroscopic adhesiolysis with the aid of ultrasound guidance as necessary. After adhesiolyis, the patients will assigned to two groups randomly,namely,the E-IUS(estrogen intrauterine stent system) group and the control group. Adhesion will be evaluated by hysteroscopy at second-look hysteroscopy before 60 after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estrogen Intrauterine Stent System | Experimental | Device: Estrogen Intrauterine Stent SystemAn Intrauterine Stent System with estrogen will be introduced into the uterine cavity after TCRA(transcervical resection of adheison). |
| Foley balloon combined with self-cross-link sodium hyaluronate gel | Other | Device: Foley balloon combined with self-cross-link sodium hyaluronate gelSubjects will be given Foley balloon (manufacturer: Zhanjiang Star Enterprise Co., Ltd.) combined with self-cross-linked sodium hyaluronate gel (manufacturer: BioRegen Biomedical (Changzhou) Co., Ltd.) after TCRA surgery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients aged 18-40 years;
Key exclusion criteria (9 listed)
- Known allergic reactions to or contraindications for silicone rubber materials, estradiol and its metabolites, Foley balloon catheters and/or intrauterine cross-linked sodium hyaluronate gel;
- ⑦ Comorbid with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal or hematopoietic system, or peptic ulcer disease, or severe diseases affecting patient survival (such as tumours or AIDS), or mental illness;
- ⑧ Drug or alcohol dependence;
- ⑨ Has enrolled in other clinical trials within the last 1 month;
- ⑩ Patients with factors considered by the investigators to be unsuitable for enrollment.
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 |
|---|---|---|
| Estrogen Intrauterine Stent SystemA Estrogen Intrauterine Stent System（E-IUS）will be introduced post-operatively. The E-IUS will be removed 60 days after surgery with continuous dydrogesterone administration for 5 days at 20 mg/d, and routine management. | Device | Estrogen Intrauterine Stent System |
| Foley balloon combined with self-cross-link sodium hyaluronate gelFoley balloon combined with self-crosslinking sodium hyaluronate gel will be introduced post-operatively，2 cycles of estrogen-progestin sequential therapy comprised of continuous estrogen and progestin added in the second half of the cycle or continuous estradiol valerate for 60 days, followed by dydrogesterone for 10 days | Device | Foley balloon combined with self-cross-link sodium hyaluronate gel |
Primary outcome
Post-operative adhesion recurrence rate(%)
Time frame: 60 days
The severity of adhesion will be assessed by hysteroscopy before and on d60 after surgery using the America Fertility Score (AFS) system. If the AFS score on D60 second-look hysteroscopy over 0 will be considered as adhesion recurrence. Post-operative adhesion recurrence rate(%)=(patients whose AFS score >0-point after surgery/All patients after surgery)X100%. The recurrence rate (%) is range from 0(Mini) to 100(Max).The lower the recurrence means the patient has a better post-operative outcome.
2 secondary outcomes
Menstrual improvement rate %(PBAC score)
Time frame: 60 days
Pregnancy rate%
Time frame: 1-2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Derived from this study: PubMed 39285313Feng L, Sun Y, Zhang S, Qian Y, Fang S, Yang B, Xu L, Li J, Niu Y, Zhang S, Zhang L, Chen J. A novel intrauterine estrogen-releasing system for preventing the postoperative recurrence of intrauterine adhesion: a multicenter randomized controlled study. BMC Med. 2024 Sep 16;22(1):395. doi: 10.1186/s12916-024-03608-4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Limin Feng principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estrogen Intrauterine Stent System and Foley balloon combined with self-cross-link sodium hyaluronate gel in people with Intrauterine Adhesion, run by Limin Feng 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Sep 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Limin Feng (+86 010-59976607, lucyfeng1966@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative adhesion recurrence rate(%) (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972032, which also lists 1 linked publication.
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 17 Sep 2021.