Increasing the Accuracy to Predict Pregnancy Success After Assisted Reproductive Therapy (ART) by Combining the ReceptIVFIty Test with Immunological Parameters
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility (IVF Patients)
- Sponsor
- Erasmus Medical Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
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.
Investigators
Sam Schoenmakers
Principal Investigator
Erasmus Medical Center
Eligibility Criteria
Inclusion Criteria
- •Indication for an IVF or IVF/ICSI procedure.
- •18 years - 42 years.
- •European origin
- •Willing to provide a vaginal swab with the ReceptIVFity-test.
- •Willing to provide informed consent.
Exclusion Criteria
- •No transferable embryos after IVF or IVF/ICSI.
- •Emergency IVF for cancer or other reasons.
- •Women with endometriosis pre-treated with an Gn-RH analogue.
- •The use of (hormonal) contraceptives or antibiotics 3 months prior to start IVF or IVF/ICSI.
- •Women unable or unwilling to agree with the procedures.
- •Women unable or unwilling to give written informed consent.
Outcomes
Primary Outcomes
Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Metabolite Analysis as Immune Signaling Modulators in IVF Patients(Baseline)