Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

NCT ID: NCT04972032

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2025-03-31

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.

Conditions

Intrauterine Adhesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Estrogen Intrauterine Stent System

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

Group Type: EXPERIMENTAL

Estrogen Intrauterine Stent System

Intervention Type: DEVICE

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

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.

Group Type: OTHER

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

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Limin Feng

OTHER

Sponsor Role: lead

Responsible Party

Limin Feng

director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Limin Feng

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

YiPuRun (Shanghai) Biotechnology Co.,Ltd.

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Limin Feng

Role: CONTACT

lucyfeng1966@163.com

+86 010-59976607

Facility Contacts

Jing Lu

Role: primary

jlu@puyibio.com

+8613482201715

References

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.

Reference Type: DERIVED

PMID: 39285313 (View on PubMed)

Other Identifiers

E-IUS

Identifier Type: -

Identifier Source: org_study_id