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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
246
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-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
YiPuRun (Shanghai) Biotechnology Co.,Ltd.
Shanghai, Shanghai Municipality, China
RECRUITINGPost-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.
Time frame: 60 days
Menstrual improvement rate %(PBAC score)
Menstrual improvement rate (evaluated by PBAC score) on 60 days after surgery
Time frame: 60 days
Pregnancy rate%
Pregnancy rate%=Number of patients with successful Pregnancy /Number of all patients)X100%
Time frame: 1-2 years
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