Infertility Assisted Reproductive Technology, Infertility (IVF Patients)
Conditions
Keywords
IVF success prediction, Vaginal microbiome, Menstrual blood immunology, Assisted reproductive technology (ART), Infertility biomarkers
Brief summary
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.
Interventions
DEVICEVaginal microbiome swab
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.
DEVICEMenstrual Blood Collection via Menstrual Cup
Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours
Sponsors
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
1. Indication for an IVF or IVF/ICSI procedure. 2. 18 years - 42 years. 3. European origin 4. Willing to provide a vaginal swab with the ReceptIVFity-test. 5. Willing to provide informed consent.
Exclusion criteria
1. No transferable embryos after IVF or IVF/ICSI. 2. Emergency IVF for cancer or other reasons. 3. Women with endometriosis pre-treated with an Gn-RH analogue. 4. The use of (hormonal) contraceptives or antibiotics 3 months prior to start IVF or IVF/ICSI. 5. Women unable or unwilling to agree with the procedures. 6. Women unable or unwilling to give written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients | Baseline and 3 months | 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. |
| Genotyping of Maternal KIR and HLA-C | Baseline | Determination of maternal Killer cell immunoglobulin-like receptor (KIR) and Major Histocompatibility Complex (HLA-C) genotypes. Unit of Measure: Genotype classification. |
| RNA Analysis of Stromal Fibroblast Cells | Baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolite Analysis as Immune Signaling Modulators in IVF Patients | Baseline | Analysis of host- and microbiome-derived metabolites serving as signaling molecules that regulate immune function. Unit of Measure: Metabolite concentrations (µmol/L). |
Countries
Netherlands
Outcome results
None listed