Mechanisms of Maternal Immune Tolerance in Early Pregnancy

NCT07297394 | Recruiting

• 1 other identifier: 2025-02262;bb25GobrechtKeller
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Immune Tolerance; In Vitro Fertilization

Keywords

Maternal Immune Tolerance; Early Pregnancy; Immune Regulation; T cells; Cytokines

Outcome Measures

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).

  Before conception, week 6-7 of pregnancy, and following implantation failure or spontaneous miscarriage, up to 12 weeks of gestation

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

Women undergoing IVF and early pregnancy

This cohort includes women undergoing in vitro fertilization (IVF)

Other: Blood sampling

Interventions

Blood sampling OTHER

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

Women undergoing IVF and early pregnancy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women undergoing in vitro fertilization (IVF) treatment at the University Hospital Basel who consent to participate in the study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ursula Gobrecht-Keller, MD

  University Hospital of Basel

  STUDY DIRECTOR

Central Study Contacts

Ursula Gobrecht-Keller, MD

CONTACT

+41 61 265 93 37; ursula.gobrecht@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 22, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)