NCT04753736撤回不适用
Intrauterine Administration and Immunophenotyping of Autologous Peripheral Blood Mononuclear Cells in Patients With Repeated Implantation Failures During Undergoing in Vitro Fertilization Treatment
Fertilys2 个研究点 分布在 1 个国家开始时间: 2021年9月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The purpose of this study is to identify a systemic immunological profile specific to patients with recurrent implantation failures (RIF) or miscarriages (RM) through blood immunophenotyping on the day of ovulation. This study also aims to determine whether the intrauterine administration of 5 million peripheral blood monocluear cells increases implantation and pregnancy rates in patients with RIF and decreases the risk of miscarriages in patients with RM, compared to what has already been published in the scientific literature
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, without a RIF status, agreeing to participate in the study and having signed the consent form to participate in the study.
- •All women aged 18 and over undergoing an IVF cycle with her partner's sperm at the Fertilys fertility center, with a RIF or RM status, agreeing to participate in the study and having signed the consent form to participate in the study.
排除标准
- •Women who need a gametes donor (eggs and / or sperm).
- •Women undergoing an IVF cycle with frozen sperm.
- •Women with autoimmune disease.
- •Women with diabetes.
- •Women with a history of chemotherapy treatment.
结局指标
主要结局
Clinical pregnancy rate
时间窗: Six to 8 weeks of gestation
Embryo implantation rate (biochemical pregnancy)
时间窗: Two weeks following embryo transfer or 3 weeks following intrauterine insemination
次要结局
- Cytokines (LIF, IL-6, IL-10, TNFα, FGF-2, VEGF, IL-8) quantification by ELISA in PBMC culture medium at Day 2(After 48 hours of culture)
- Peripheral blood mononuclear cells populations distribution at Day 2(After 48 hours of culture)
- Peripheral blood mononuclear cells populations (PBMC) distribution at Day 0(The day 0 of the patient's ovulation)
研究者
研究点 (2)
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