Immune Tolerance, In Vitro Fertilization, Pregnancy
Conditions
Keywords
Maternal Immune Tolerance, Early Pregnancy, Immune Regulation, T cells, Cytokines
Brief summary
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.
Detailed description
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.
Interventions
OTHERBlood sampling
Blood samples will be analyzed before and during early pregnancy as well as after early miscarriage
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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. 1. where the patient (pregnant person) was ≥ 18 years of age. 2. where the patient (pregnant person) signed a written informed consent.
Exclusion criteria
1. Certain maternal infections (HIV, Hepatitis B, Hepatitis C, Syphilis) 2. Patients under immunosuppressive medications (at time of blood sample collection)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune cell composition in peripheral blood | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Single-cell RNA sequencing analysis to characterize transcriptional phenotypes of PBMCs. This includes identification of differentially expressed genes, gene modules, and transcription factor activity profiles associated with pregnancy and pregnancy failure. |
| 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 | Assessment of clonal expansion and contraction in TCR and BCR (B cell receptor) repertoires using bulk and single-cell sequencing. |
Countries
Switzerland
Contacts
CONTACTUrsula Gobrecht-Keller, MD
STUDY_DIRECTORUrsula Gobrecht-Keller, MD
University Hospital of Basel
Outcome results
None listed