Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-07 @ 12:48 AM
Study NCT ID:
NCT06394466
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2024-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thyroid Function and Autoimmunity in Subfertility Women and Assisted Reproductive Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 453}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-27', 'studyFirstSubmitDate': '2024-04-27', 'studyFirstSubmitQcDate': '2024-04-27', 'lastUpdatePostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TSH levels during assisted reproductive therapy and first trimester', 'timeFrame': '90 days', 'description': 'TSH, free and total thyroxine, and ioduria in the first trimester'}], 'secondaryOutcomes': [{'measure': 'Association between AMH levels and detectable categories of TPO-Ab or Tg-Ab', 'timeFrame': '30 days', 'description': 'AMH, TPO-Ab and Tg-Ab dosages'}, {'measure': 'Correlation between AMH and TSH', 'timeFrame': '30 days', 'description': 'AMH and TSH dosages'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti mullerian hormone', 'Thyroid autoimmunity', 'Antithyroid antibodies', 'Infertility'], 'conditions': ['Ovarian Failure', 'Thyroid Diseases']}, 'descriptionModule': {'briefSummary': 'The assessment of ovarian reserve is well established based on the dosage of anti-Mullerian hormone (AMH). The clinical applicability of detecting thyroid autoantibodies levels has been discussed as a potential marker of low-grade inflammation. There are no studies about the detection of these autoantibodies in infertile women. Our objective is to evaluate the association between ovarian reserve and thyroid function and its autoimmunity in infertile women seeking for assisted reproductive treatment (ART).Evaluation ot thyroid function in the first trimester in also be evaluated in women submitted to ART.', 'detailedDescription': 'The assessment of ovarian reserve is well established based on the dosage of anti-Mullerian hormone (AMH). The clinical applicability of detecting thyroid autoantibodies levels has been discussed as a potential marker of low-grade inflammation. There are no studies about the detection of these autoantibodies in infertile women. Evaluation of TSH profile during ovarian stimulation in ART is also debated in literature with conflicting results. Our objective is to evaluate the association between ovarian reserve and thyroid function and its autoimmunity in infertile women seeking for assisted reproductive treatment (ART) and TSH profile during ovarian stimulation and during the first trimester.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who looked for assisted reproduction and went through the process of ovarian stimulation and oocyte retrieval. The study was carried out with data from the first initial clinic appointment at Vida Assisted Reproduction clinic - Fertility Center (Rio de Janeiro, Brazil). Data collected from the patients in the initial clinical history were: chronological age, cause(s) of infertility, comorbidities and use of medications.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria were: women attended in the outpatient clinic with baseline exams before ART and during ovarian stimulation between July 2021 and July 2023\n\nExclusion Criteria:\n\n* Exclusion criteria were: patients with known clinical hypothyroidism, patients using medications that may influence the hypothalamic-pituitary-thyroid axis, such as glucocorticoids in supraphysiological doses; or that could interfere with thyroid hormone metabolism (lithium, amiodarone and aspirin in anti-inflammatory dosages).'}, 'identificationModule': {'nctId': 'NCT06394466', 'briefTitle': 'Thyroid Function and Autoimmunity in Subfertility Women and Assisted Reproductive Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Rio de Janeiro State University'}, 'officialTitle': 'Evaluation of Thyroid Function and Autoimmunity in Subfertility Women and Thyroid Hormone Levels in the First Trimester of Assisted Reproduction', 'orgStudyIdInfo': {'id': 'Y201420y'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women undergoing ovarian stimulation in our ART clinic', 'description': 'Inclusion criteria were: women attended in the outpatient clinic with baseline exams before ART and during ovarian stimulation between July 2021 and July 2023. Exclusion criteria were: patients with known clinical hypothyroidism, patients using medications that may influence the hypothalamic-pituitary-thyroid axis, such as glucocorticoids in supraphysiological doses; or that could interfere with thyroid hormone metabolism (lithium, amiodarone and aspirin in anti-inflammatory dosages).', 'interventionNames': ['Other: Non Applicable']}], 'interventions': [{'name': 'Non Applicable', 'type': 'OTHER', 'description': 'Non Applicable', 'armGroupLabels': ['Women undergoing ovarian stimulation in our ART clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22631-000', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Vida Assisted Reproduction clinic - Fertility Center', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Ana BW Tavares, pHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rio de Janeiro State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rio de Janeiro State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Yuri Ian Lima Alves de Oliveira', 'investigatorAffiliation': 'Rio de Janeiro State University'}}}}