ReceptIVFity & Immunology in ART

NCT06709976 | Enrolling By Invitation

• 1 other identifier: OZBS72.19236
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility (IVF Patients); Infertility Assisted Reproductive Technology

Keywords

IVF success prediction; Vaginal microbiome; Menstrual blood immunology; Assisted reproductive technology (ART); Infertility biomarkers

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Metabolite Analysis as Immune Signaling Modulators in IVF Patients

  Baseline

Interventions

Vaginal microbiome swab DEVICE

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.

Menstrual Blood Collection via Menstrual Cup DEVICE

Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Women who receive IVF or IVF/ICSI treatment
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Indication for an IVF or IVF/ICSI procedure.
• years - 42 years.
• European origin
• Willing to provide a vaginal swab with the ReceptIVFity-test.
• Willing to provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal microbiome sample Self-collected Menstrual Blood

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: September 6, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)