Effects of Exogenous Recombinant GCSF in Patients With Repeated Implantation Failure - A Randomized Single-blind Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pregnancy and Implantation
研究概览
简要总结
The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. In addition, following the injection, the level of G-CSF in the bloodstream will be verified.
详细描述
Recently, scientists have been interested in G-CSF (Granulocyte - Colony Stimulating Factor) and the latter has seen its use grow in reproductive pathology.
G -CSF, a true center pivot, would act concurrently on oocyte quality and endometrial receptivity, improving:
- Immune tolerance
- The self-healing of oocyte chromosome abnormalities
- The adherence of the embryo
The injection of G-CSF molecule has been used in different circumstances. One of its uses, among others, is to help rebuild the immune system in patients undergoing chemotherapy. Some studies have been conducted in patients having embryo implantation problems; they have demonstrated improved rates of pregnancy and childbirth after treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 18 and 37
- •Indication of the Antagonist IVF protocol or indication of a substituted frozen embryo transfer
- •Subjects with repetitive embryo implantation failure meaning: a history of 3 embryos transferred including frozen embryo without a positive pregnancy test for women 35 years and younger
- •Subjects with repetitive embryo implantation failure meaning: a history of 4 embryos transferred including frozen embryo without a positive pregnancy test for women between the ages of 35 and
- •Negative repetitive implantation failure work up
排除标准
- •Renal failure or cardiac failure
- •Chronic neutropenia
- •Past or present cancer history
- •Sickle cell anemia
- •Lithium treatment
- •Voluntary withdrawal from the study
- •Use of concomitant medication: DHEA (dehydroepiandrosterone ), CoQ10 (coenzyme Q10), Growth Hormone and Viagra
研究组 & 干预措施
Filgrastim
Injection Filgrastim 300 ug intravaginally during an IVF cycle or during an embryo transfer
干预措施: Filgrastim (Drug)
Sodium Chloride
Injection of 1 ml of Sodium Chloride intravaginally during an IVF cycle or during an embryo transfer cycle.
干预措施: Filgrastim (Drug)
结局指标
主要结局
Pregnancy and Implantation
时间窗: up to 3 years
Measure the pregnancy and embryo implantation rate post G-CSF injection
Dosage of G-CSF
时间窗: up to 3 years
Measure dosage of G-CSF in the bloodstream on the day of oocyte retrieval and measure the implantation rate as well as pregnancy rate following the G-CSF injection
次要结局
未报告次要终点