Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

Sponsor

Limin Feng (Other)

Overall Status

Recruiting

CT.gov ID

NCT04972032

Collaborator

(none)

246

Enrollment

Location

Arms

53.9

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intrauterine Adhesion	Device: Estrogen Intrauterine Stent System Device: Foley balloon combined with self-cross-link sodium hyaluronate gel	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

246 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System

Actual Study Start Date :

Sep 2, 2020

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Estrogen Intrauterine Stent System An Intrauterine Stent System with estrogen will be introduced into the uterine cavity after TCRA(transcervical resection of adheison).	Device: Estrogen Intrauterine Stent System 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.
Other: 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.	Device: Foley balloon combined with self-cross-link sodium hyaluronate gel 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

Arm

Intervention/Treatment

Experimental: Estrogen Intrauterine Stent System

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

Device: Estrogen Intrauterine Stent System

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.

Other: 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.

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

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

Outcome Measures

Primary Outcome Measures

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

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%

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.