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临床试验/NCT01715974
NCT01715974Unknown3 期

Administration of GM-CSF in Women With Recurrent Implantation Failure in IVF Cycles and Egg Donation Cycles

Centre for Endocrinology and Reproductive Medicine, Italy1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年12月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
140
试验地点
1
主要终点
pregnancy outcome

研究概览

简要总结

The purpose of this study is to determine whether in Assisted Reproductive Technologies the treatment with GM-CSF, a growth factor working on stem cells, may improve the pregnancy rate and pregnancy outcome in patients experiencing recurrent implantation failure in IVF cycles.

详细描述

The GM-CSF is a cytokine promoting leukocyte growth, but also trophoblast development. In this randomized sudy investigators will test this cytokine as a treatment for recurrent implantation failure after IVF, at leat three failed previous IVF attempts.

The study will be conducted in 100 women with recurrent implantation failure of egg donation cycles. The inclusion criteria will be, at least three previous failed Egg Donation attempts where at least 4 good blastocysts were transferred, women less than 50 years old, absence of systemic diseases. These women will undergo egg donation cycle and they will randomly divided in two groups: one (50 women) will be treated with subcutaneous GM-CSF 60 micrograms/day from the day of transfer to the day of β-hCG test, and if it will be positive the treatment will be continued for other 40 days; the group of control will be treated with subcutaneous saline solution infusion in the same way of the study group. Primary outcomes will be considered: pregnancy rate and live birth rate, the of β-hCG levels at 14/21/28 and 35 days after embryo transfer.

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 (Participant)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women 50 years old or less with three or more previous egg donation cycles failed,
  • with a total of at least 4 blastocysts replaced in uterus

排除标准

  • chromosomal defects in the patients,
  • metabolic diseases (diabetes etc.)
  • genetic diseases (thalassemia, cystic fibrosis, etc.)

研究组 & 干预措施

CONTROL

Placebo Comparator

patients with recurrent implantation failure treated with PLACEBO (saline solution) from the day of embryo transfer through the day of beta hCG test

干预措施: CONTROL (Drug)

GM-CSF group

Experimental

patients with recurrent implantation failure treated with GM-CSF (30 micrograms/day) from the day of embryo transfer through the day of beta hCG test

干预措施: GM-CSF group (Drug)

结局指标

主要结局

pregnancy outcome

时间窗: 12 months

The number of patients pregnant after treatment with GM-CSF (30 microgram/day)compared with the number of patients pregnant in the control group

次要结局

  • implantation rate(12 months)

研究者

发起方
Centre for Endocrinology and Reproductive Medicine, Italy
申办方类型
Network
责任方
Sponsor

研究点 (1)

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