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NCT Number: NCT07297394

Mechanisms of Maternal Immune Tolerance in Early Pregnancy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Location status: Recruiting

Location contact

Ursula Gobrecht-Keller, MD

CONTACT

[email protected]

+41 61 265 93 37

Ursula Gobrecht-Keller, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

  • where the patient (pregnant person) was ≥ 18 years of age.
  • where the patient (pregnant person) signed a written informed consent.

Exclusion criteria

  • Certain maternal infections (HIV, Hepatitis B, Hepatitis C, Syphilis)
  • Patients under immunosuppressive medications (at time of blood sample collection)

Treatment and study plan

Blood sampling

Other

Blood samples will be analyzed before and during early pregnancy as well as after early miscarriage

Primary outcomes

  1. Immune cell composition in peripheral blood

    Time frame: 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 outcomes

  1. Transcriptional profiles of peripheral blood mononuclear cell (PBMC) subsets associated with pregnancy outcome (scRNA-seq)

    Time frame: 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.

  2. T-cell and B-cell receptor repertoire dynamics (TCR/BCR sequencing)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ursula Gobrecht-Keller, MD

CONTACT

[email protected]

+41 61 265 93 37

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 22, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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