The Impact of Uterine Immunity and Its Alterations on the Embryo Implantation Process
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infertility Assisted Reproductive Technology. Basic parameters: 20 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
- Italy
- 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
What Impact Does Uterine Immunity Have on the Success of Euploid Thawed Embryos?
Overview
Evaluation of uterine immunity, histological picture, and endometrial microbiome for embryo implantation
Primary outcome measures
- Characterise the molecular immunologic mechanism underlying embryo implantation [Time frame: from enrollment to the pregnancy test (12 days after embryo transfer)]
Secondary outcome measures (1)
- to study the possible correlations of the expression of the interleukins involved in the implantation process of the embryo [Time frame: The endometrial biopsy on which the interleukin dosage will be done, will be taken one month before the embryo transfer]
Eligibility criteria
Inclusion criteria
Female patients aged >18 and <43 years at the time of embryo transfer.
Transfer of cryopreserved embryos diagnosed as euploid through preimplantation genetic testing for aneuploidy (PGT-A).
Embryo transfer performed at the blastocyst stage.
Exclusion criteria
Patients with an intrauterine device (IUD) in situ within the three months prior to study enrollment.
Presence of autoimmune diseases and/or ongoing treatment with corticosteroids.
Structural or pathological abnormalities of the uterine cavity, including but not limited to polyps, intramural myomas measuring 2-4 cm, submucosal fibroids, uterine septum, or hydrosalpinx, identified during study participation. Patients with a history of these conditions may be included if the pathology has been resolved prior to the initiation of any study-related procedures or sample collection.
Presence of severe or uncontrolled fungal or viral infections which, in the opinion of the principal investigator, may compromise the patient's ability to participate or affect the integrity of study outcomes.
Any medical condition or illness that is unstable, poses a potential risk to patient safety, or may interfere with adherence to the study protocol.
Patients lacking a confirmed preimplantation genetic diagnosis of euploidy.
Patients with a clinical diagnosis of endometriosis or adenomyosis.
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
Italy · 1 center
- MOMO' Fertilife — Bisceglie
Publications
- Nagaeva O, Jonsson L, Mincheva-Nilsson L. Dominant IL-10 and TGF-beta mRNA expression in gammadeltaT cells of human early pregnancy decidua suggests immunoregulatory potential. Am J Reprod Immunol. 2002 Jul;48(1):9-17. doi: 10.1034/j.1600-0897.2002.01131.x. PMID 12322898
- Vitoratos N, Papadias C, Economou E, Makrakis E, Panoulis C, Creatsas G. Elevated circulating IL-1beta and TNF-alpha, and unaltered IL-6 in first-trimester pregnancies complicated by threatened abortion with an adverse outcome. Mediators Inflamm. 2006;2006(4):30485. doi: 10.1155/MI/2006/30485. PMID 17047289
- Lombardelli L, Logiodice F, Kullolli O, Haller H, Agostinis C, Bulla R, Rukavina D, Piccinni MP. At Embryo Implantation Site IL-35 Secreted by Trophoblast, Polarizing T Cells towards IL-35+ IL-10+ IL-4+ Th2-Type Cells, Could Favour Fetal Allograft Tolerance and Pregnancy Success. Int J Mol Sci. 2022 Apr 28;23(9):4926. doi: 10.3390/ijms23094926. PMID 35563316
- Ledee N, Petitbarat M, Prat-Ellenberg L, Dray G, Cassuto GN, Chevrier L, Kazhalawi A, Vezmar K, Chaouat G. The uterine immune profile: A method for individualizing the management of women who have failed to implant an embryo after IVF/ICSI. J Reprod Immunol. 2020 Nov;142:103207. doi: 10.1016/j.jri.2020.103207. Epub 2020 Sep 14. PMID 32971456
- Szekeres-Bartho J. The Role of Progesterone in Feto-Maternal Immunological Cross Talk. Med Princ Pract. 2018;27(4):301-307. doi: 10.1159/000491576. Epub 2018 Jun 27. PMID 29949797
- Piccinni MP, Raghupathy R, Saito S, Szekeres-Bartho J. Cytokines, Hormones and Cellular Regulatory Mechanisms Favoring Successful Reproduction. Front Immunol. 2021 Jul 28;12:717808. doi: 10.3389/fimmu.2021.717808. eCollection 2021. PMID 34394125
- Mahajan D, Kumar T, Rath PK, Sahoo AK, Mishra BP, Kumar S, Nayak NR, Jena MK. Dendritic Cells and the Establishment of Fetomaternal Tolerance for Successful Human Pregnancy. Arch Immunol Ther Exp (Warsz). 2024 May 23;72(1). doi: 10.2478/aite-2024-0010. eCollection 2024 Jan 1. PMID 38782369
- Zhou J, Yan P, Ma W, Li J. Cytokine modulation and immunoregulation of uterine NK cells in pregnancy disorders. Cytokine Growth Factor Rev. 2025 Feb;81:40-53. doi: 10.1016/j.cytogfr.2024.11.007. Epub 2024 Nov 23. PMID 39603954
Identifiers
NCT: NCT07120958 · 32/cf/2025