Clinical trial NCT06709976: ReceptIVFity &amp;amp; Immunology in ART
Official title: Increasing the Accuracy to Predict Pregnancy Success After Assisted Reproductive Therapy (ART) by Combining the ReceptIVFIty Test with Immunological Parameters
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Infertility (IVF Patients)
Infertility Assisted Reproductive Technology
Keywords: IVF success prediction
Vaginal microbiome
Menstrual blood immunology
Assisted reproductive technology (ART)
Infertility biomarkers
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Immune Cell Phenotype and Function in Menstrual Blood Stratified by Vaginal Microbiome in IVF Patients
timeFrame: Baseline and 3 months
measure: Genotyping of Maternal KIR and HLA-C
timeFrame: Baseline
measure: RNA Analysis of Stromal Fibroblast Cells
timeFrame: Baseline
Secondary outcomes:
measure: Metabolite Analysis as Immune Signaling Modulators in IVF Patients
timeFrame: Baseline
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: South-Holland
Study officials:
References: