A Randomized Controlled Trial of the Effect of the Granulocyte-macrophage Colony Stimulating Factor Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium
试验速览
- 阶段
- 不适用
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- the endometrial thickness
研究概览
简要总结
The purpose of this study is to investigate the efficacy of the granulocyte-macrophage colony stimulating factor(GM-CSF) gel on the endometrial thickness in infertile women with thin endometrium.
详细描述
The thin endometrium is detrimental to embryo implantation, probability of clinical pregnancy for an endometrial thickness ≤ 7 mm was significantly lower compared with cases with endometrial thickness > 7 mm. It has been reported the granulocyte colony stimulating factor (G-CSF) increased the endometrial thickness and pregnancy rate of infertile women with thin endometrium during IVF cycle. However, most of the researches were retrospective and small sample size, and the results were conflicted among them. GM-CSF is another member of CSF superfamily, recalling more macrophage than G-CSF, which could be more effective in local homeostasis maintain and wound repair. GM-CSF has been widely used in skin repair after burn. It was also found the GM-CSF and its receptor in endometrium. In the past year, the investigators tried GM-CSF irrigation in 21 women with thin endometrium and most of them received GM-CSF after hysteroscopic examination or slight adhesion relaxing, and the preliminary data suggested that the GM-CSF may promote the endometrial growth. Does the GM-CSF gel can improve the endometrial thickness? Therefore, this study was conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Woman undergoes IVF treatment, 18-40 years old
- •The endometrial thickness <7mm on the day of human chorionic gonadotropin during IVF or after taking oral estradiol valerate 6mg/d for 14 days.
- •Embryo transfer is cancelled because of thin endometrium
- •No intrauterine adhesion according to the 3-D ultrasonography
排除标准
- •Systemic diseases unable to conceive
- •Chromasome abnormal
- •History of G-CSF or GM-CSF allergy or untoward effect
- •Thin endometrium related to clomid
- •Severe or moderate uterine adhesion
- •The influence factor of embryo implantation: hydrosalpinx, endometriosis, adenomyosis,myoma of uterus
- •Uterine malformation, adenomyosis, uterine leiomyoma sized more than 2cm.
- •Patients who is allergic to granulocyte-macrophage colony stimulating factor
- •Patients with inflammation of reproductive organs, pelvic cavity inflammation, malignant tumor of reproductive organs and other systemic diseases that could cause metrorrhagia
研究组 & 干预措施
GM-CSF
Hysteroscopy will be arranged to confirm the uterine cavity is normal and there is no significant intrauterine adhesion.
3ml GM-CSF gel will be irrigated into the uterine cavity immediately when hysteroscopy is complete. Then same dose gel will be given every other day twice.
干预措施: GM-CSF (Drug)
GM-CSF
Hysteroscopy will be arranged to confirm the uterine cavity is normal and there is no significant intrauterine adhesion.
3ml GM-CSF gel will be irrigated into the uterine cavity immediately when hysteroscopy is complete. Then same dose gel will be given every other day twice.
干预措施: 17-ß estradiol (Drug)
Control
Hysteroscopy will be arranged to confirm the uterine cavity is normal and there is no significant intrauterine adhesion.
After hysteroscopy examination, nothing was applied to the uterine cavity.
干预措施: 17-ß estradiol (Drug)
结局指标
主要结局
the endometrial thickness
时间窗: 1 months after hysteroscopy examination
the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound
次要结局
- embryo transfer cancelation rate(2 months after hysteroscopy examination)
- pregnancy rate(3 months after hysteroscopy examination)
- uterine artery blood supply markers(1 months after hysteroscopy examination)
研究者
Xiaona Lin
Vice Director of gynaecology and obstetrics
Sir Run Run Shaw Hospital
