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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal microbiome swab | Device | All swabs were collected using FLOQSwabsâ„¢ (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. | ||
| Menstrual Blood Collection via Menstrual Cup | Device | Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
Women who receive IVF or IVF/ICSI treatment
Women aged 18-42 expected to undergo their first IVF/IVF-ICSI cycle within the next two months. The routine IVF/IVF-ICSI procedure will occur irrespective of their participation or the test outcomes.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | South Holland | 3015GD | Netherlands |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Vaginal microbiome sample Self-collected Menstrual Blood