The goal of this clinical non-invasive observational pilot study is to improve the prediction of pregnancy success after In Vitro Fertilisation (IVF)/IVF -Intracytoplasmic Sperm Injection (ICSI) treatment by examining the vaginal microbiome and the immunological profile of menstrual blood in women (18-42) years old) undergoing their first IVF/IVF/ICSI treatment. The main questions it aims to answer are: What is the ReceptIVFity profile (low, medium, or high) of the vaginal microbiome in these women? How do the endometrial-derived lymphocytes respond to different immune stimuli and microbiota? Can the endometrial stromal cells decidualize effectively in the presence or absence of specific microbiota? Participants will: Self-perform a vaginal swab to determine the ReceptIVFity profile of their vaginal microbiome. Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours for immunological analysis.
Study Type
OBSERVATIONAL
Enrollment
50
All swabs were collected using FLOQSwabs™ (Copan Italia SpA, Brescia, Italy). The patients were instructed to spread the labia with one hand, insert the swab 3-5 cm beyond the vaginal orifice with the other hand, and rotate the swab along the vaginal wall for 10-15 seconds.
Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients
Analysis of monocyte, Natural Killer (NK) cell, T lymphocytes, regulatory T lymphocytes, and T helper cell phenotypes in menstrual blood. Immune responses, including cytokine production and immune marker regulation, will be quantified. Unit of Measure: Percentage of cell type, cytokine concentrations in pg/mL.
Time frame: Baseline and 3 months
Genotyping of Maternal KIR and HLA-C
Determination of maternal Killer cell immunoglobulin-like receptor (KIR) and Major Histocompatibility Complex (HLA-C) genotypes. Unit of Measure: Genotype classification.
Time frame: Baseline
RNA Analysis of Stromal Fibroblast Cells
Analysis of RNA from stromal fibroblast cells to determine expression of tissue adaptation markers (pre-decidualization). Gene expression levels (e.g., fold change, normalized counts).
Time frame: Baseline
Metabolite Analysis as Immune Signaling Modulators in IVF Patients
Analysis of host- and microbiome-derived metabolites serving as signaling molecules that regulate immune function. Unit of Measure: Metabolite concentrations (µmol/L).
Time frame: Baseline
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