Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis

Limin Feng

Status: Enrolling

Conditions: Intrauterine Adhesion

Treatments: Device: Foley balloon combined with self-cross-link sodium hyaluronate gel; Device: Estrogen Intrauterine Stent System

Study type: Interventional

Funder types: Other

Identifiers

NCT04972032

E-IUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 246 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

246 participants in 2 patient groups

Estrogen Intrauterine Stent System

Experimental group

Description:

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

Treatment:

Device: Estrogen Intrauterine Stent System

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

Other group

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.

Treatment:

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