ReceptIVFity & Immunology in ART

• Conditions: Infertility (IVF Patients); Infertility Assisted Reproductive Technology

• Registration Number: NCT06709976
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-06
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, South-Holland, Netherlands