Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT05446012
Status:
COMPLETED
Last Update Posted:
2022-12-06
First Post:
2022-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Ectopic Pregnancy and Thyroid Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D002828', 'term': 'Choristoma'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013960', 'term': 'Thyroid Function Tests'}], 'ancestors': [{'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2022-06-26', 'studyFirstSubmitQcDate': '2022-06-30', 'lastUpdatePostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thyroid dysfunction and ectopic pregnancy', 'timeFrame': 'Through study completion, an average of 5 months', 'description': 'TSH, T3, T4, TT3, TT4, Thyroglobulin, Anti peroxidase antibody, Anti thyroglobulin antibody,TSH receptors antibody will be measured in patients diagnosed with ectopic pregnancy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid disorders', 'pregnancy', 'Ectopic'], 'conditions': ['Ectopic Pregnancy', 'Thyroid Diseases', 'Pregnancy, Ectopic']}, 'referencesModule': {'references': [{'pmid': '32089504', 'type': 'BACKGROUND', 'citation': 'Mendez-Tepepa M, Zepeda-Perez D, Espindola-Lozano M, Rodriguez-Castelan J, Arroyo-Helguera O, Pacheco P, Nicolas-Toledo L, Cuevas-Romero E. Hypothyroidism modifies differentially the content of lipids and glycogen, lipid receptors, and intraepithelial lymphocytes among oviductal regions of rabbits. Reprod Biol. 2020 Jun;20(2):247-253. doi: 10.1016/j.repbio.2020.02.004. Epub 2020 Feb 20.'}, {'pmid': '17653299', 'type': 'BACKGROUND', 'citation': 'Oner J, Oner H. Immunodetection of thyroid hormone receptor (alpha1/alpha2) in the rat uterus and oviduct. Acta Histochem Cytochem. 2007 Jul 3;40(3):77-81. doi: 10.1267/ahc.06026.'}, {'pmid': '25405800', 'type': 'BACKGROUND', 'citation': 'Anaya-Hernandez A, Rodriguez-Castelan J, Nicolas L, Martinez-Gomez M, Jimenez-Estrada I, Castelan F, Cuevas E. Hypothyroidism affects differentially the cell size of epithelial cells among oviductal regions of rabbits. Reprod Domest Anim. 2015 Feb;50(1):104-11. doi: 10.1111/rda.12455. Epub 2014 Nov 18.'}]}, 'descriptionModule': {'briefSummary': 'Fallopian tubes participate in the incorporation of gametes and embryos into the endometrial cavity. It also provides an optimal environment for flattening and early embryonic development. Tubal pathologies can cause both primary and secondary infertility. This condition has been associated with overt and subclinical hypothyroidism. However, the effects of hypothyroidism on tubal activity are not fully known. Although a few animal experiment studies on this subject have been published, there is no study on this subject in the literature. Demonstrating that epithelial and smooth muscle cells of rat fallopian tubes express thyroid receptors in animal experiments showed that fallopian tubes are targets for thyroid hormones. Again, in an animal experiment study, it was revealed that thyroid hormones have an important control on glycogen and lipid storage, lipid signaling and lymphocyte infiltration, which have an important role in maintaining the microenvironment in the rat fallopian tubes. This microenvironment is necessary for fertilization, sperm capacitation and gamete development. In another animal experimental study, it was thought that changes in the size of the epithelium of the fallopian tubes and cell metabolism in hypothyroid rabbits may affect oviductal activity and reproductive functions. An ectopic pregnancy is defined as a pregnancy implanted outside of the uterus. Ectopic pregnancy \\>98% implants in the fallopian tube. The etiology of ectopic pregnancy is unclear, but tubal implantation is probably due to impaired embryo-tubal transport. This is due to changes in the tubal environment. Based on this information, we aim to determine the possible relationship between hypothyroidism and ectopic pregnancy in humans in our study.', 'detailedDescription': "Our aim in this study is to determine the possible relationship between hypothyroidism and ectopic pregnancy in humans. For this purpose, 40 patients with a diagnosis of ectopic pregnancy and 40 patients with diagnosis of early pregnancy followed in Siirt Training and Research Hospital between 30 June 2022 and 30 October 2022 will be included in the study. The patient's age, pregnancy history, medical history and laboratory findings (TSH, sT3, sT4, TT3, TT4, thryoglobulin , Anti-Peroxidase Antibody, Anti-thryoglobulin Antibody, TSH receptors antibody ) will be recorded. In the light of the information gathered, it will be tried to determine whether there is a relationship between thyroid dysfunctions and ectopic pregnancy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'women over 18 years of age diagnosed with ectopic pregnancy or early pregnancy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years of age\n* Having an early pregnancy or ectopic pregnancy\n\nExclusion Criteria:\n\n* using medications due to thyroid gland dysfunction\n* history of ectopic pregnancy\n* history of tubal surgery'}, 'identificationModule': {'nctId': 'NCT05446012', 'briefTitle': 'Relationship Between Ectopic Pregnancy and Thyroid Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Siirt University'}, 'officialTitle': 'Ectopic Pregnancy and Thyroid Disorders', 'orgStudyIdInfo': {'id': 'SiirtU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women diagnosed with ectopic pregnancy (n: 40)', 'description': 'thyroid function tests (TSH, sT3, sT4, TT3, TT4, thryoglobulin, Anti-Peroxidase Antibody, Anti- thryoglobulin Antibody, TSH receptors antibody levels) will be done in women diagnosed with ectopic pregnancy', 'interventionNames': ['Diagnostic Test: thyroid function tests']}, {'label': 'Control group pregnants (n:40)', 'description': 'thyroid function tests (TSH, sT3, sT4, TT3, TT4, thryoglobulin, Anti-Peroxidase Antibody, Anti- thryoglobulin Antibody, TSH receptors antibody levels) will be done in pregnant women in early pregnancy week.', 'interventionNames': ['Diagnostic Test: thyroid function tests']}], 'interventions': [{'name': 'thyroid function tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood sample for thyroid function tests (TSH,T3,T3,Anti peroxidase antibody, anti thyroglobulin antibody)', 'armGroupLabels': ['Control group pregnants (n:40)', 'women diagnosed with ectopic pregnancy (n: 40)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Siirt', 'country': 'Turkey (Türkiye)', 'facility': 'Siirt Üniversity Medical Faculty', 'geoPoint': {'lat': 37.9293, 'lon': 41.94134}}], 'overallOfficials': [{'name': 'Şerif Aksin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siirt University Medical Faculty Obstetrics and Gynecology Departmant'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siirt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Serif Aksin', 'investigatorAffiliation': 'Siirt University'}}}}