The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- second diagnostic hysteroscopy
研究概览
简要总结
To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.
详细描述
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 20-40 years；
- •previously diagnostic hysteroscopy confirmed adhesion score >5， according to the American Fertility Society （AFS）classification of IUA；
- •complains of menstruation disorder and reproductive dysfunction；
- •informed consent.
排除标准
- •premature menopause,
- •presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
- •presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
- •adhesions limited to the lower uterine cavity or the cervical canal.
研究组 & 干预措施
dried biological amnion graft
patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
干预措施: dried biological amnion graft (Procedure)
dried biological amnion graft
patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
干预措施: Foley balloon (Device)
dried biological amnion graft
patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
干预措施: estradiol valerate tablets+dydrogesterone Tablets (Drug)
Foley catheter balloon only
patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
干预措施: Foley balloon (Device)
Foley catheter balloon only
patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
干预措施: estradiol valerate tablets+dydrogesterone Tablets (Drug)
结局指标
主要结局
second diagnostic hysteroscopy
时间窗: postoperation three to four months
次要结局
未报告次要终点