Prevention of Intrauterine Adhesions After Hysteroscopic Metroplasty With Autocross-linked Hyaluronic Acid Gel
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Change in Formation of intrauterine adhesions
研究概览
简要总结
The septate uterus is the most common structural uterine anomaly. It results from failure of the partition between the two fused Müllerian ducts to resorb;it is associated with the highest incidence of reproductive failure and with first- and second-trimester pregnancy loss and infertility.
Hysteroscopic division of the uterine septum is performed using microscissors, electrosurgery, or laser. Several studies shown significant improvement in pregnancy outcome after hysteroscopic metroplasty.
Purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine adhesions, through second look office hysteroscopy after three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •uterine septum
- •history of ≥1 miscarriage or infertility;
- •desire to have children in the future
排除标准
- •pregnancy;
- •menopause;
- •precancerous state or malignancy of the reproductive organs;
- •benign lesions in the myometrium of the uterine fundus (myomas or adenomyosis)
- •lesions distorting the uterine cavity (submucosal myomas or intrauterine adhesions) on ultrasonography;
- •withdrawal of patient consent;
- •rare complex uterine congenital anomalies without an ASRM classification such as uterine septum with double cervix ;
- •presence of external intercornual cleft;
- •incomplete (internal fundal indentation 10 mm) or non-standardized septum resection (internal fundal indentation ,10 mm and uterine myometrial thickness .10 mm at the fundus), confirmed intraoperatively
- •excessive fundal incision (uterine myometrial thickness ,6 mm at the fundus confirmed intraoperatively)
结局指标
主要结局
Change in Formation of intrauterine adhesions
时间窗: baseline (operative isteroscopy and three months
次要结局
未报告次要终点
研究者
Stefano Angioni
Associate Professor
University of Cagliari