Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-04 @ 7:06 PM
Study NCT ID:
NCT03843034
Status:
UNKNOWN
Last Update Posted:
2023-11-02
First Post:
2019-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Markers in Autoimmune Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Endometrial biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-01', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-02-14', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endometrial cytokine LIF concentration (pg/ml)', 'timeFrame': 'February 18, 2019 - August 31, 2020', 'description': 'The endometrial cytokine LIF profile in endometrial biopsies of women with autoimmune disease will be determined and compared to normal, fertile women (pg/mL)'}], 'secondaryOutcomes': [{'measure': 'Blood concentration of cytokines such as LIF, IL6, TNFα TGFα (pg/ml)', 'timeFrame': 'February 18, 2019 - August 2020', 'description': 'The blood cytokines concentration will be compared between the autoimmune diseases group and the control group. Moreover the cytokines concentration in blood and endometrial tissue will be compared.'}, {'measure': 'endometrial concentration of cytokines such as, IL6, TNFα TGFα (pg/ml)', 'timeFrame': 'February 18, 2019 - August 2020', 'description': 'The endometrial cytokines concentration will be compared between the autoimmune diseases group and the control group. Moreover the cytokines concentration in blood and endometrial tissue will be compared.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometrial Receptivity', 'Fertility', 'Autoimmune Diseases']}, 'descriptionModule': {'briefSummary': 'Autoimmune diseases cause a decreased endometrial receptivity during the implantation window, most likely changing the endometrial cytokines pattern due to dysregulation of the inflammatory processes.Therefore, endometrial cytokine profiles will be compared in women with autoimmune disease and normal, fertile women.\n\nThe collected endometrial tissue and blood samples will be examined for the cytokines profiling using commercially available ELISA kits.\n\nThe sample size was calculated choosing, as primary outcome, changes in endometrial LIF concentration between the disease and control Group, which is our main goal. Given a type I error of 5%, a maximum of 21 women are needed for each Group to reach the desired power of 80% to detect the least changes in concentrations.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with thyroid diseases, rheumatoid arthritis, inflammatory bowel diseases, multiple sclerosis, diabetes mellitus, and psoriasis will be included in the study Group (Age: 20-40 years old). Healthy women receiving assisted reproduction due to male infertility will be included in the control Group (Age: 20-40 years old).', 'genderDescription': 'It is a study on endometrial factors in female infertility', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudy group:\n\n\\* Females with infertility combined with autoimmune disease and in fertility treatment.\n\nControl group:\n\n\\* Female from couples with severe male infertility and in fertility treatment.\n\nExclusion Criteria:\n\n* Language problems to such an extent that the subjects do not understand the scope of the study.\n* Abnormal follicle stimulating hormone (FSH),\n* Abnormal antral follicles Count\n* Genital infections\n* Endometriosis\n* Tubal occlusion\n* Polycystic ovarian syndrome'}, 'identificationModule': {'nctId': 'NCT03843034', 'briefTitle': 'Endometrial Markers in Autoimmune Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Endometrial Markers in Women With Autoimmune Diseases Receiving Assisted Reproduction', 'orgStudyIdInfo': {'id': 'Lab.Reprod.Biol. - Odense.04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Infertile women with autoimmune disease', 'interventionNames': ['Genetic: Measure endometrial markers']}, {'label': 'Control group', 'description': 'Women from couples with severe male infertility', 'interventionNames': ['Genetic: Measure endometrial markers']}], 'interventions': [{'name': 'Measure endometrial markers', 'type': 'GENETIC', 'description': 'Endometrial biopsies will be taken from participants in both groups', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Jens Fedder', 'investigatorAffiliation': 'Odense University Hospital'}}}}