Mechanisms of Maternal Immune Tolerance in Early Pregnancy

University Hospital Basel

Status: Not yet enrolling

Conditions: In Vitro Fertilization; Immune Tolerance; Pregnancy

Treatments: Other: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT07297394

2025-02262 bb25GobrechtKeller;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

Women undergoing IVF and early pregnancy

Description:

This cohort includes women undergoing in vitro fertilization (IVF)

Treatment:

Other: Blood sampling