Mechanisms of Maternal Immune Tolerance in Early Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
where the patient (pregnant person) was ≥ 18 years of age.
where the patient (pregnant person) signed a written informed consent.
Disqualifiers
Certain maternal infections (HIV, Hepatitis B, Hepatitis C, Syphilis)
Patients under immunosuppressive medications (at time of blood sample collection)
Trial population
Women undergoing in vitro fertilization (IVF) treatment at the University Hospital Basel who consent to participate in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood sampling
Other interventionBlood samples will be analyzed before and during early pregnancy as well as after early miscarriage
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Women undergoing IVF and early pregnancy1 intervention
Trial outcomes
Primary outcomes
1
Immune cell composition in peripheral blood
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).
Time frame
Before conception, week 6-7 of pregnancy, and following implantation failure or spontaneous miscarriage, up to 12 weeks of gestationSecondary outcomes
1
Transcriptional profiles of peripheral blood mononuclear cell (PBMC) subsets associated with pregnancy outcome (scRNA-seq)
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.
Time frame
Before conception, week 6-7 of pregnancy, and following implantation failure or spontaneous miscarriage, up to 12 weeks of gestation2
T-cell and B-cell receptor repertoire dynamics (TCR/BCR sequencing)
Assessment of clonal expansion and contraction in TCR and BCR (B cell receptor) repertoires using bulk and single-cell sequencing.
Time frame
Before conception, week 6-7 of pregnancy, and following implantation failure or spontaneous miscarriage, up to 12 weeks of gestationSponsors and contacts
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Source ClinicalTrials.gov