How a mother's immune system accepts pregnancy in the first trimester
Mechanisms of Maternal Immune Tolerance in Early Pregnancy
University Hospital, Basel, Switzerland · NCT07297394
We will test how the immune system changes in the first trimester in people undergoing IVF to see which immune patterns support implantation and help prevent early miscarriage.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel) |
| Trial ID | NCT07297394 on ClinicalTrials.gov |
What this trial studies
This is an observational, longitudinal study of people undergoing IVF/ICSI that collects blood before embryo transfer, during the first trimester, and after any miscarriage. Samples will be analyzed for immune cell composition, activation states, and cytokine profiles using advanced immunological assays. The design tracks immune changes from pre-implantation through early gestation to identify cellular and molecular signatures linked to successful implantation and tolerance. Results aim to generate markers that could inform future predictive tests or targeted interventions.
Who should consider this trial
Good fit: People aged 18 or older undergoing IVF/ICSI (including those who become pregnant or experience failed implantation/miscarriage) who can provide written informed consent and attend blood draws at the study site are ideal candidates.
Not a fit: Individuals with HIV, hepatitis B or C, syphilis, or those taking immunosuppressive medications are excluded and thus will not be eligible, and participants should not expect direct therapeutic benefit from this observational study.
Why it matters
Potential benefit: If successful, the study could identify blood-based immune markers that help predict or prevent early pregnancy loss and guide personalized approaches to support implantation.
How similar studies have performed: Previous observational work has linked T cell subsets and cytokine patterns to pregnancy outcomes, but causal mechanisms remain unproven, so this study builds on associative findings rather than testing an established therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Ursula Gobrecht-Keller, MD
- Email: ursula.gobrecht@usb.ch
- Phone: +41 61 265 93 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy, Immune Tolerance, In Vitro Fertilization, Maternal Immune Tolerance, Early Pregnancy, Immune Regulation, T cells, Cytokines