Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

Not Applicable

Recruiting

• Conditions: Intrauterine Adhesion
• Interventions: Device: Estrogen Intrauterine Stent System; Device: Foley balloon combined with self-cross-link sodium hyaluronate gel

• Registration Number: NCT04972032
• Lead Sponsor: Limin Feng

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.

Study Timeline

• Study Start: 2020-09-02
• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-07-12
• Study First Posted: 2021-07-22
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-17
• Primary Completion: 2024-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 246

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estrogen Intrauterine Stent System	Estrogen Intrauterine Stent System	An 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	Foley balloon combined with self-cross-link sodium hyaluronate gel	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.

Primary Outcome Measures

Name	Time	Method
Post-operative adhesion recurrence rate(%)	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.

Secondary Outcome Measures

Name	Time	Method
Menstrual improvement rate %(PBAC score)	60 days	Menstrual improvement rate (evaluated by PBAC score) on 60 days after surgery
Pregnancy rate%	1-2 years	Pregnancy rate%=Number of patients with successful Pregnancy /Number of all patients）X100%

Trial Locations

Locations (1)

YiPuRun (Shanghai) Biotechnology Co.,Ltd.; 🇨🇳 Shanghai, Shanghai, China