Intrauterine Adhesion Clinical Trial
Official title:
Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon and amniotic products can improve clinical outcomes? Therefore, this study was conducted.
The diaposable balloon uterine(a special intrauterine balloon) is usually inserted into the
uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery.
Another group, the diaposable balloon uterin and dried biological amnion will be inserted
into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after
surgery.Several investigators demonstrated its favorable effect in the recurrence of adhesion
after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially
designed to fit into the cavity of the uterus, and usually removed on the 7th day after
surgery.
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model:
Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
;
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