The Value of Using Platelet Rich Plasma After Hysteroscopic Lysis of Severe Intrauterine Adhesions (A Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Prevent recurrence of intrauterine adhesions
研究概览
简要总结
The aim of present study is to evaluate the effect of the use of platelet rich plasma in decreasing recurrence of intrauterine adhesions after its lysis.
详细描述
Research question:
In women undergoing hysteroscopic adhesiolysis, does postoperative use of platelet rich plasma decrease the recurrence of intrauterine adhesions?
Research hypothesis:
In women undergoing hysteroscopic adhesiolysis for Asherman's syndrome, postoperative use of platelet rich plasma may decrease the recurrence of intrauterine adhesions.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertility due to Asherman's syndrome with history of hypomenorrhea or amenorrhea and infertility and evaluated by office hysteroscopy to confirm the presence of sever adhesions according to American fertility society.
排除标准
- •Hb < 11 g/dL, platelets < 150.000/mm3
- •Patient taking anticoagulant.
- •Patient taking NSAID in the 10 days before procedure.
- •Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
- •Active cervical or uterine infection.
研究组 & 干预措施
Study Group
Platelet Rich Plasma
干预措施: Platelet Rich Plasma (Biological)
Control Group
Intrauterine Foley's Catheter
干预措施: Intrauterine Foley's Catheter (Device)
结局指标
主要结局
Prevent recurrence of intrauterine adhesions
时间窗: Reassessed after one month
Prevent recurrence of intrauterine adhesions after hysteroscopic adhesiolysis assessed by office hysteroscopy according to American Fertility Society adhesion score: 1. Extent of cavity involved: ( \<1/3, 1/3 - 2/3, \>2/3 ) 2. Type of adhesions: (filmy, filmy to dense, dense) 3. menstrual pattern (normal, hypomenorrhea, amenorrhea)
次要结局
- Return of menses(Reassessed after one month)
研究者
Ahmed Mohamed Mahmoud Abd El-Wahab Torky
Principal Investigator
Ain Shams Maternity Hospital