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临床试验/NCT04100655
NCT04100655Unknown不适用

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

Sir Run Run Shaw Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2019年10月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaona Lin

Vice Director of gynaecology and obstetrics

Sir Run Run Shaw Hospital

研究点 (1)

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