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Enrolling by Invitation

NCT Number: NCT06709976

ReceptIVFity & Immunology in ART

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.

Enrolling by Invitation

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Key information

Conditions

Infertility (IVF Patients) Genital Diseases Infertility Infertility Assisted Reproductive Technology Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Metabolite Analysis as Immune Signaling Modulators in IVF Patients

    Time frame: Baseline

    Analysis of host- and microbiome-derived metabolites serving as signaling molecules that regulate immune function.

    Unit of Measure: Metabolite concentrations (µmol/L).

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Increasing the Accuracy to Predict Pregnancy Success After Assisted Reproductive Therapy (ART) by Combining the ReceptIVFIty Test with Immunological Parameters

Acronym: R-IMinART

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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