Clinical trial NCT04972032: Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis
Official title: Prevention of Postoperative Adhesion Recurrence by Estrogen-intrauterine Stent System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: Intrauterine adhesion
recurrence
estrogen
intrauterine stent
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 246
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Post-operative adhesion recurrence rate(%)
timeFrame: 60 days
Secondary outcomes:
measure: Menstrual improvement rate %(PBAC score)
timeFrame: 60 days
measure: Pregnancy rate%
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: YiPuRun (Shanghai) Biotechnology Co.,Ltd.
state: Shanghai
Study officials:
affiliation: Beijing Tiantan Hospital
name: Limin Feng
role: PRINCIPAL_INVESTIGATOR
References: