ReceptIVFity & Immunology in ART
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vaginal microbiome swab, Menstrual Blood Collection via Menstrual Cup.
- Who it may be relevant to
- Registry conditions: Infertility (IVF Patients), Infertility Assisted Reproductive Technology. Basic parameters: 18 years — 42 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Increasing the Accuracy to Predict Pregnancy Success After Assisted Reproductive Therapy (ART) by Combining the ReceptIVFIty Test with Immunological Parameters
Overview
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
- Device Vaginal 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. - Device Menstrual Blood Collection via Menstrual Cup
Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours
Primary outcome measures
- Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients [Time frame: Baseline and 3 months]
- Genotyping of Maternal KIR and HLA-C [Time frame: Baseline]
- RNA Analysis of Stromal Fibroblast Cells [Time frame: Baseline]
Secondary outcome measures (1)
- Metabolite Analysis as Immune Signaling Modulators in IVF Patients [Time frame: Baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Erasmus Medical Center — Rotterdam
Identifiers
NCT: NCT06709976 · OZBS72.19236