Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis
Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System
1 other identifier
interventional
246
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2020
CompletedFirst Submitted
Initial submission to the registry
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
July 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedSeptember 17, 2021
September 1, 2021
3.5 years
June 30, 2021
September 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
60 days
Secondary Outcomes (2)
Menstrual improvement rate %(PBAC score)
60 days
Pregnancy rate%
1-2 years
Study Arms (2)
Estrogen Intrauterine Stent System
EXPERIMENTALAn 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
OTHERSubjects 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.
Interventions
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-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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Limin Fenglead
Study Sites (1)
YiPuRun (Shanghai) Biotechnology Co.,Ltd.
Shanghai, Shanghai Municipality, China
Related Publications (1)
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.
PMID: 39285313DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Limin Feng
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- director
Study Record Dates
First Submitted
June 30, 2021
First Posted
July 22, 2021
Study Start
September 2, 2020
Primary Completion
March 1, 2024
Study Completion
March 1, 2025
Last Updated
September 17, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share