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Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

Primary Purpose

Intrauterine Adhesion

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Estrogen Intrauterine Stent System
Foley balloon combined with self-cross-link sodium hyaluronate gel
Sponsored by
Limin Feng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Adhesion focused on measuring Intrauterine adhesion, recurrence, estrogen, intrauterine stent

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • YiPuRun (Shanghai) Biotechnology Co.,Ltd.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Estrogen Intrauterine Stent System

Foley balloon combined with self-cross-link sodium hyaluronate gel

Arm Description

An Intrauterine Stent System with estrogen will be introduced into the uterine cavity after TCRA(transcervical resection of adheison).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Menstrual improvement rate %(PBAC score)
Menstrual improvement rate (evaluated by PBAC score) on 60 days after surgery
Pregnancy rate%
Pregnancy rate%=Number of patients with successful Pregnancy /Number of all patients）X100%

Full Information

First Posted
June 30, 2021
Last Updated
September 10, 2021
Sponsor
Limin Feng
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1. Study Identification

Unique Protocol Identification Number
NCT04972032
Brief Title
Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis
Official Title
Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Limin Feng

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion
Keywords
Intrauterine adhesion, recurrence, estrogen, intrauterine stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Estrogen Intrauterine Stent System
Arm Type
Experimental
Arm Description
An Intrauterine Stent System with estrogen will be introduced into the uterine cavity after TCRA(transcervical resection of adheison).
Arm Title
Foley balloon combined with self-cross-link sodium hyaluronate gel
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Estrogen Intrauterine Stent System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Foley balloon combined with self-cross-link sodium hyaluronate gel
Intervention Description
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
Primary Outcome Measure Information:
Title
Post-operative adhesion recurrence rate(%)
Description
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.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Menstrual improvement rate %(PBAC score)
Description
Menstrual improvement rate (evaluated by PBAC score) on 60 days after surgery
Time Frame
60 days
Title
Pregnancy rate%
Description
Pregnancy rate%=Number of patients with successful Pregnancy /Number of all patients）X100%
Time Frame
1-2 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The female patients after TCRA surgery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Limin Feng
Phone
+86 010-59976607
Email
lucyfeng1966@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Limin Feng
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
YiPuRun (Shanghai) Biotechnology Co.,Ltd.
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Lu
Phone
+8613482201715
Email
jlu@puyibio.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

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