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Starting soon Not applicable

Study of Endometrial Immune and Microbiological Modifications in Cases of Recurrent Implantation Failure and/or Recurrent Pregnancy Loss

NCT07265505 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-04
Last updated
2026-02-05

Condition(s) studied

Recurrent Implantation FailureRecurrent Pregnancy LossInfertility, FemaleEndometrial DiseasesEndometritisEndometriosisAdenomyosis

Investigational drug(s) / intervention(s)

Endometrial BiopsyVaginal SwabBlood samplePelvic ultrasound (±pelvic MRI)

Endometrial Biopsy: Endometrial biopsy with Cornier Pipelle (part of the treatment in the RIF/RPL group and some patients of the control group / added for the research for the other patients of the control group)

Vaginal Swab: Vaginal sample collection using a cotton swab. Part of the treatment

Blood sample: Peripheral blood draw. Part of the treatment + 10 mL additional for research

Pelvic ultrasound (±pelvic MRI): Pelvic ultrasound (±pelvic MRI). Part of the treatment

Study summary

The IMERR study aims to improve understanding of certain causes of infertility related to recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL), conditions that affect many women undergoing assisted reproductive technology (ART). Despite medical advances, some patients repeatedly fail to achieve pregnancy, or experience repeated miscarriages. These situations may be linked to subtle immune or microbial disturbances in the uterus. This study seeks to identify immune and microbiological profiles in the endometrium during the implantation window-a crucial period when the embryo attaches to the uterine wall. We will compare women who have experienced RIF and/or RPL with women who have had no such history. Blood and uterine samples will be analyzed to investigate whether certain immune or microbial features are associated with these reproductive failures. The ultimate goal is to uncover predictive factors that may explain why some women experience implantation failure or pregnancy loss, and to lay the foundation for future personalized treatments to improve reproductive outcomes.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
35 Years
Healthy volunteers
No
Inclusion Criteria: * Female aged ≥18 and \<36 years * Undergoing assisted reproductive technology (ART) in a fertility center * Covered by the French national health insurance system * Belonging to one of two groups: * Study group: history of recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL) * Control group: no history of RIF or RPL Exclusion Criteria: * Pregnant at inclusion * Refusal to provide written informed consent * Antibiotic use within one month prior to endometrial biopsy Positive serology for hepatitis B, hepatitis C or HIV * Uterine anatomical abnormalities (e.g., polyps, cavity-distorting fibroids, untreated hydrosalpinx) * Known chromosomal abnormality in either partner * Known autoimmune disease, thrombophilia, or antiphospholipid antibody syndrome * Persons under legal protection (e.g., guardianship, curatorship)

Primary outcome measure(s)

  • Profiling of endometrial immune cell populations — Baseline
    Profiling of endometrial immune cell populations (proportion of subpopulation) during the implantation window using single-cell transcriptomics and/or flow cytometry. Endometrial biopsies will be collected during the implantation window. Immune cell populations will be characterized using either single-cell RNA sequencing (scRNA-seq) and /or multiparametric flow cytometry, depending on technical feasibility and sample quality. For scRNA-seq, transcriptomic analysis will be performed (e.g., using the 10x Genomics platform), and immune cell types will be identified via clustering and annotation algorithms. For flow cytometry, immune subsets will be identified and quantified based on surface marker expression. Comparisons of immune profiles will be made between women with and without a history of RIF and/or RPL.

Trial sites (1)

FacilityCityRegionStatus
Service de Gynécologie Obstétrique II et Médecine de la Reproduction - Cochin Hospital Paris IDF
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07265505 on ClinicalTrials.gov ↗ ← All trials in France