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Mechanisms of Maternal Immune Tolerance in Early Pregnancy

NCT ID: NCT07297394

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Immune Tolerance In Vitro Fertilization

Keywords

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Maternal Immune Tolerance Early Pregnancy Immune Regulation T cells Cytokines

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women undergoing IVF and early pregnancy

This cohort includes women undergoing in vitro fertilization (IVF)

Blood sampling

Intervention Type OTHER

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

Interventions

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Blood sampling

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ursula Gobrecht-Keller, MD

Role: STUDY_DIRECTOR

University Hospital of Basel

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Ursula Gobrecht-Keller, MD

Role: CONTACT

Phone: +41 61 265 93 37

Email: [email protected]

Facility Contacts

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Ursula Gobrecht-Keller, MD

Role: primary

Other Identifiers

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2025-02262;bb25GobrechtKeller

Identifier Type: -

Identifier Source: org_study_id