Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT03452735
Status:
UNKNOWN
Last Update Posted:
2018-07-23
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fertility Study of Women With Chronic Inflammatory Rheumatism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D001171', 'term': 'Arthritis, Juvenile'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D000844', 'term': 'Ankylosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-19', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Birth rate after spontaneous or induced pregnancy', 'timeFrame': 'One day', 'description': 'Birth rate after spontaneous or induced pregnancy in women who have tried to procreate in the chronic inflammatory rheumatism group and in the control group.'}], 'secondaryOutcomes': [{'measure': 'Rates of ectopic pregnancy, early or late spontaneous miscarriage', 'timeFrame': 'one day', 'description': 'Rates of ectopic pregnancy, early or late spontaneous miscarriage, early or late pregnancy, children born dead, preterm birth in the CIR group and in the control group'}, {'measure': 'Design time', 'timeFrame': 'One day', 'description': 'Design time in the CIR group and in the control group'}, {'measure': 'Birth rate according to the treatments used', 'timeFrame': 'One day', 'description': 'Birth rate in the CIR group according to the treatments used'}, {'measure': 'Birth rate according to the activity of the disease', 'timeFrame': 'One day', 'description': 'Birth rate in the CIR group according to the activity of the disease'}, {'measure': 'Rates of desire for pregnancy', 'timeFrame': 'One day', 'description': 'Rates of desire for pregnancy and study of the reasons for this lack of desire for pregnancy in the CIR group and in the control group'}, {'measure': 'Rates of sexual dysfunction', 'timeFrame': 'One day', 'description': 'Rates of sexual dysfunction in the CIR group and in the control group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic inflammatory rheumatism', 'Fertility', 'Procreation'], 'conditions': ['Arthritis, Psoriatic', 'Arthritis, Rheumatoid', 'Ankylosing Spondylitis', 'Chronic Juvenile Arthritis']}, 'descriptionModule': {'briefSummary': 'Etiopathogenesis of Chronic inflammatory rheumatisms (CIR) includes genetic, autoimmune and environmental factors. Their impact on the quality of life is important, leading to a sometimes severe disability. Thus they are likely to affect female fertility through several mechanisms, including autoimmune since the association between immunity and fertility has already been demonstrated in other autoimmune diseases.\n\nThis study wants to evaluate and compare the birth rate between CIR and control group.', 'detailedDescription': 'Data collection will be carried out using a questionnaire submitted to women in charge of the rheumatology department of the University Hospital of Toulouse and having agreed to participate:\n\n* women with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis or Chronic juvenile arthritis for the chronic inflammatory rheumatism group\n* women with a mechanical rheumatic pathology for the control group\n\nThe primary endpoint was birth rate after spontaneous or induced pregnancy in patients who attempted to procreate, in the CIR group and in the control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Case group: patient with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis\n* Control Group: patient not suffering from RIC, having consulted in rheumatology for a mechanical pathology (eg osteoarthritis, mechanical low back pain ...)', 'genderDescription': 'study on woman fertility', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis, Chronic Inflammatory Rheumatism\n* Patient diagnosed before the age of 40\n* Patient having given her no opposition to her participation in research\n* For the control group: patient not suffering from chronic inflammatory rheumatism, having consulted in Rheumatology for a mechanical pathology\n\nExclusion Criteria:\n\n* Patient\\> 40 years old at the time of diagnosis\n* Patient with insufficient medical data (treatments)'}, 'identificationModule': {'nctId': 'NCT03452735', 'acronym': 'FERTIRHUM', 'briefTitle': 'Fertility Study of Women With Chronic Inflammatory Rheumatism', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Fertility Study of Women With Chronic Inflammatory Rheumatism', 'orgStudyIdInfo': {'id': 'RC31/17/0446'}, 'secondaryIdInfos': [{'id': '2017-A03539-44', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients diagnosed before age 40', 'description': 'Patient between 18 and 50 years-old with Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Chronic juvenile arthritis, Chronic Inflammatory Rheumatism who will answer to a questionnaire about fertility', 'interventionNames': ['Other: Questionnaire about fertility']}, {'label': 'Control Group', 'description': 'Patient between the ages of 18 and 50 years, not diagnosed with Chronic inflammatory rheumatism, having consulted in Rheumatology for a mechanical pathology, presenting no chronic pathology, having no chemo or radiotherapy or immunosuppressive therapy, or pelvic surgery before age 40 years who will answer to a questionnaire about fertility', 'interventionNames': ['Other: Questionnaire about fertility']}], 'interventions': [{'name': 'Questionnaire about fertility', 'type': 'OTHER', 'description': 'Sending a questionnaire about fertility that will have to be returned to us in order to be included in the study. The questionnaires, anonymous, will be numbered according to their order of return.', 'armGroupLabels': ['Control Group', 'patients diagnosed before age 40']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean Parinaud, MD', 'role': 'CONTACT', 'email': 'parinaud.j@chu-toulouse.fr', 'phone': '05 67 77 10 02', 'phoneExt': '33'}], 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Jean Parinaud, MD', 'role': 'CONTACT', 'email': 'parinaud.j@chu-toulouse.fr', 'phone': '5 67 77 11 02', 'phoneExt': '33'}, {'name': 'Isabelle Olivier, PhD', 'role': 'CONTACT', 'email': 'olivier.i@chu-toulouse.fr', 'phone': '5 61 77 70 51', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Jean Parinaud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}