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临床试验/IRCT2013012211430N3
IRCT2013012211430N3已完成2 期

Efficacy of Granulocyte Colony Stimulating Factor(G-CF) on treatment of unexplained recurrent miscarriage in Avicena center

Reaserch center of Avicenna0 个研究点目标入组 68 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
68

研究概览

简要总结

Objective
Endometrium undergoes several changes in structure and cellular compose during pregnancy. GCS-F (Granulocyte Colony-stimulating Factor) is an important cytokine with critical role in embryo implantation and pregnancy. The previous studies showed that that transvaginal endometrial perfusion with G-CSF might be helpful for improvement of implantation rate among patients with thin endometrium and repeated implantation failure (RIF). The aim of present study was to evaluate the impact of intrauterine injection of G-CSF in patients that suffering from unexplained recurrent miscarriage (RM).
Materials and Methods
In present randomized clinical trial a total of 68 patients were randomly allocated into two study groups including intrauterine G-CSF(300µg, Filgrastim, Switzerland) injection and control group (no G-CSF injection).All patients were in I/O (Ovulation Induction) cycle. In G-CSF group, intrauterine injection of G-CSF was done twice in cycle. All enrolled patients were under 40 years old and had at least two times unexplained pregnancy loss. Pregnancy was evaluated by titer of ßhCG, presence of gestational sac (implantation) was assessed by vaginal ultrasonography and finally clinical pregnancy was confirmed by detection of fetal heart rate (FHR).
Results
Eighteen out of 68 patients were excluded from the final analysis due to different reasons. No significant difference were observed between two study groups when we compared the rate of chemical pregnancy (26.1% vs. 29.6%, P=1.000), implantation (26.1% vs. 22.2%, Fisher’s exact test P=0.673), clinical pregnancy (17.4% vs. 11.1%, Fisher’s exact test P: 0.657) and abortion (8.7% vs. 18.5% Fisher’s exact test P=0.921).
Conclusion
In contrast to possible effect of G-CSF on improvement of implantation rate that revealed by some other studies, based on the result of present study we couldn’t suggest intrauterine injection of G-CSF for improvement of clinical pregnancy rate and reduce of abortion among patients with unexplained RM. Further molecular biology studies are needed to clarify the mechanism in which G-CSF affects the pregnancy process.

研究设计

研究类型
Interventional

入排标准

年龄范围
no limit 至 40 years(—)
性别
Female

入选标准

  • patients with 3 or more abortion or 2 consecutive abortion; under 40 years old; normal karyotype; normal uterus; without infectious or immunologic or endocrine or thrombotic disorders; normal thyroid function,TPO<=500; FSH<=10; LH=normal and FBS=normal.
  • Exclusion criteria: cancer and no acceptance to participate in the study.

排除标准

  • 未提供

研究者

发起方
Reaserch center of Avicenna

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