Mechanisms of Maternal Immune Tolerance in Early Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Immune cell composition in peripheral blood
研究概览
简要总结
This study explores the mechanisms of maternal immune tolerance in early pregnancy by characterizing immune cell profiles and functional pathways during the first trimester. The goal is to identify immunological factors that support healthy gestation and prevent complications such as miscarriages.
详细描述
Maternal immune tolerance is essential for a successful pregnancy, as the maternal immune system must accept the semi-allogeneic fetus while maintaining defense against pathogens. Failure in this delicate balance can lead to complications such as recurrent miscarriage, preeclampsia, or implantation failure. Although several immune cell types, including T cells and regulatory pathways, are thought to play a role, the precise mechanisms underlying maternal immune adaptation during early pregnancy remain poorly understood.
This observational study investigates immunological changes occurring before and during early pregnancy and miscarriage in women undergoing in vitro fertilization (IVF). Blood samples will be collected at multiple predefined time points: prior to embryo transfer and during the first trimester of pregnancy as well as after miscarriage. These samples will be analyzed for immune cell composition, activation status, and cytokine profiles using advanced immunological assays. The longitudinal design allows for tracking dynamic changes in immune regulation from pre-implantation through early gestation.
The primary objective is to identify cellular and molecular signatures associated with maternal immune tolerance and successful implantation. Insights gained from this study may inform future strategies to predict and prevent pregnancy complications such as early miscarriage related to immune dysregulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Blood from patients will be included before and during pregnancies (or failed implantation) conceived through IVF/ICSI (Intracytoplasmic Sperm Injection) treatment and in case of miscarriage.
- •where the patient (pregnant person) was ≥ 18 years of age.
- •where the patient (pregnant person) signed a written informed consent.
排除标准
- •Certain maternal infections (HIV, Hepatitis B, Hepatitis C, Syphilis)
- •Patients under immunosuppressive medications (at time of blood sample collection)
研究组 & 干预措施
Women undergoing IVF and early pregnancy
This cohort includes women undergoing in vitro fertilization (IVF)
干预措施: Blood sampling (Other)
结局指标
主要结局
Immune cell composition in peripheral blood
时间窗: Before conception, week 6-7 of pregnancy, and following implantation failure or spontaneous miscarriage, up to 12 weeks of gestation
Characterization of immune cell subsets (e.g., T cells, regulatory T cells, natural killer cells (NK cells)) in blood samples collected at predefined time points (before embryo transfer and during early pregnancy and in case of early miscarriage).
次要结局
- T-cell and B-cell receptor repertoire dynamics (TCR/BCR sequencing)(Before conception, week 6-7 of pregnancy, and following implantation failure or spontaneous miscarriage, up to 12 weeks of gestation)
- Transcriptional profiles of peripheral blood mononuclear cell (PBMC) subsets associated with pregnancy outcome (scRNA-seq)(Before conception, week 6-7 of pregnancy, and following implantation failure or spontaneous miscarriage, up to 12 weeks of gestation)