The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Adhesion reformation rate
研究概览
简要总结
The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.
详细描述
After hysteroscopic adhesiolysis, patients with moderate to severe intrauterine adhesions will be allocated into 2 groups randomly, with COOK ballon and estrogen and progesterone sequential therapy given to prevent adhesion routinely. 7 day later, G-CSF or normal saline will be injected into the uterine cavity by Tom catheter after removing the balloon respectively. A second hysteroscopic examination will be performed in 2 months to check up the adhesion reformation. In addition, the endometrial thickness after surgery and fertility outcome will be followed up.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Moderate and severe intrauterine adhesion patients(AFS score ≥5)
- •age 18-40
- •first time receiving hysteroscopic adhesiolysis
- •provided COOK balloon as adjuvant adhesion prevention treatment
- •accepting randomized trial
排除标准
- •Mild adhesion patients
- •uterine shape can't be restored in the end of surgery
- •abnormal chromosome phenotype
- •systemic disease
- •no fertility desire
- •contradiction of G-CSF injection.
研究组 & 干预措施
G-CSF
G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
干预措施: G-CSF (Drug)
G-CSF
G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
干预措施: hormone therapy (Drug)
G-CSF
G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
干预措施: Cook balloon (Other)
Normal saline
equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
干预措施: Normal saline (Drug)
Normal saline
equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
干预措施: hormone therapy (Drug)
Normal saline
equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.
干预措施: Cook balloon (Other)
结局指标
主要结局
Adhesion reformation rate
时间窗: 2 months after first surgery
Adhesion reformation rate after first adhesiolysis
次要结局
- Live birth rate(4 years after first surgery)
- Pregnancy rate(3 years after first surgery)
研究者
Xiaona Lin
MD
Sir Run Run Shaw Hospital