An observational study in Infertility (IVF Patients) and Infertility Assisted Reproductive Technology, sponsored by Erasmus Medical Center. Enrolling by invitation at 1 site in Netherlands. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Erasmus Medical Center · Observational
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 714 observational studies indexed under Infertility.
Browse Infertility studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
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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.
Exclusion Criteria:
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
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
Plan to share: No
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