Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT07120958
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-13
First Post:
2025-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Uterine Immunity and Its Alterations on the Embryo Implantation Process
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Endometrial biopsy stored at -80 C°'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'to assess whether progesterone levels can alter the immune response', 'timeFrame': 'the same day of the embryo transfer', 'description': 'immunofluorescence device; unit of measure: ng/ml'}], 'primaryOutcomes': [{'measure': 'Characterise the molecular immunologic mechanism underlying embryo implantation', 'timeFrame': 'from enrollment to the pregnancy test (12 days after embryo transfer)', 'description': 'The main objective of this research is to characterise the molecular immunologic mechanism underlying embryo implantation. These outcomes will be assessed regarding the percentage of expressivity of some interleukins in pregnant couples and those who are not'}], 'secondaryOutcomes': [{'measure': 'to study the possible correlations of the expression of the interleukins involved in the implantation process of the embryo', 'timeFrame': 'The endometrial biopsy on which the interleukin dosage will be done, will be taken one month before the embryo transfer', 'description': 'to study the possible correlations of the expression of the interleukins involved with related anatomical and histological pictures. Interleukin dosage will be assessed through PCR. The unit of measure is ng/ml.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interleukin', 'ngs', 'art', 'icsi', 'implantation', 'euploid', 'uterine immunity'], 'conditions': ['Infertility Assisted Reproductive Technology']}, 'referencesModule': {'references': [{'pmid': '12322898', 'type': 'BACKGROUND', 'citation': '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': '17047289', 'type': 'BACKGROUND', 'citation': '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': '35563316', 'type': 'BACKGROUND', 'citation': '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': '32971456', 'type': 'BACKGROUND', 'citation': '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': '29949797', 'type': 'BACKGROUND', 'citation': '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': '34394125', 'type': 'BACKGROUND', 'citation': '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': '38782369', 'type': 'BACKGROUND', 'citation': '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': '39603954', 'type': 'BACKGROUND', 'citation': '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': '33715911', 'type': 'BACKGROUND', 'citation': 'Parasar P, Guru N, Nayak NR. Contribution of macrophages to fetomaternal immunological tolerance. Hum Immunol. 2021 May;82(5):325-331. doi: 10.1016/j.humimm.2021.02.013. Epub 2021 Mar 11.'}, {'pmid': '32973809', 'type': 'BACKGROUND', 'citation': 'Wang W, Sung N, Gilman-Sachs A, Kwak-Kim J. T Helper (Th) Cell Profiles in Pregnancy and Recurrent Pregnancy Losses: Th1/Th2/Th9/Th17/Th22/Tfh Cells. Front Immunol. 2020 Aug 18;11:2025. doi: 10.3389/fimmu.2020.02025. eCollection 2020.'}, {'pmid': '12650238', 'type': 'BACKGROUND', 'citation': 'Szekeres-Bartho J. Immunological relationship between the mother and the fetus. Int Rev Immunol. 2002 Nov-Dec;21(6):471-95. doi: 10.1080/08830180215017.'}, {'pmid': '33133091', 'type': 'BACKGROUND', 'citation': 'Abu-Raya B, Michalski C, Sadarangani M, Lavoie PM. Maternal Immunological Adaptation During Normal Pregnancy. Front Immunol. 2020 Oct 7;11:575197. doi: 10.3389/fimmu.2020.575197. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of uterine immunity, histological picture, and endometrial microbiome for embryo implantation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women who undertake ART treatment in South Italy', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFemale patients aged \\>18 and \\<43 years at the time of embryo transfer.\n\nTransfer of cryopreserved embryos diagnosed as euploid through preimplantation genetic testing for aneuploidy (PGT-A).\n\nEmbryo transfer performed at the blastocyst stage.\n\nExclusion Criteria:\n\nPatients with an intrauterine device (IUD) in situ within the three months prior to study enrollment.\n\nPresence of autoimmune diseases and/or ongoing treatment with corticosteroids.\n\nStructural 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.\n\nPresence 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.\n\nAny medical condition or illness that is unstable, poses a potential risk to patient safety, or may interfere with adherence to the study protocol.\n\nPatients lacking a confirmed preimplantation genetic diagnosis of euploidy.\n\nPatients with a clinical diagnosis of endometriosis or adenomyosis."}, 'identificationModule': {'nctId': 'NCT07120958', 'acronym': 'UTIMEE', 'briefTitle': 'The Impact of Uterine Immunity and Its Alterations on the Embryo Implantation Process', 'organization': {'class': 'OTHER', 'fullName': 'Momo Fertilife'}, 'officialTitle': 'What Impact Does Uterine Immunity Have on the Success of Euploid Thawed Embryos?', 'orgStudyIdInfo': {'id': '32/cf/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'endometrial biopsy with pregnancy'}, {'label': 'endometrial biopsy without pregancy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76011', 'city': 'Bisceglie', 'state': 'BT', 'country': 'Italy', 'facility': "MOMO' Fertilife", 'geoPoint': {'lat': 41.24264, 'lon': 16.50104}}], 'overallOfficials': [{'name': 'Domenico Baldini, Degree in Medicine and Surgery', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Momo Fertilife'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Momo Fertilife', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bari', 'class': 'OTHER'}, {'name': 'University of Florence', 'class': 'OTHER'}, {'name': 'Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'IVF Lab Manager', 'investigatorFullName': 'Daniele Ferri', 'investigatorAffiliation': 'Momo Fertilife'}}}}