Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

Intrauterine Adhesion Clinical Trial

Official title:

Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972032
• Other study ID #: E-IUS
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: March 2025

Study information

• Verified date: September 2021
• Source: Beijing Tiantan Hospital
• Contact: Limin Feng
• Phone: +86 010-59976607
• Email: lucyfeng1966[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: March 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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; ? 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; ? Perimenopausal and menopausal females; ? 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; ? Drug or alcohol dependence; ? Has enrolled in other clinical trials within the last 1 month; ? Patients with factors considered by the investigators to be unsuitable for enrollment.

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

Intervention

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.
• 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

Locations

Country	Name	City	State
China	YiPuRun (Shanghai) Biotechnology Co.,Ltd.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Limin Feng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Menstrual improvement rate %(PBAC score)	Menstrual improvement rate (evaluated by PBAC score) on 60 days after surgery	60 days
Secondary	Pregnancy rate%	Pregnancy rate%=Number of patients with successful Pregnancy /Number of all patients)X100%	1-2 years