Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-06 @ 12:34 AM
Study NCT ID:
NCT06545994
Status:
RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum kisspeptin, insulin, testosterone and blood glucose in the first trimester, second trimester and late pregnancy.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-10', 'studyFirstSubmitDate': '2024-08-06', 'studyFirstSubmitQcDate': '2024-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic changes of serum kisspeptin levels throughout pregnancy in PCOS patients', 'timeFrame': '40 weeks', 'description': 'Serum kisspeptin levels in the first, second trimester and late pregnancy of PCOS patients and control group.'}], 'secondaryOutcomes': [{'measure': 'The association between serum Kisspeptin levels and the prevalence of GDM in PCOS patients', 'timeFrame': '40 weeks', 'description': 'The predictive value of serum Kisspeptin levels in the first trimester for GDM in PCOS patients'}, {'measure': 'The association between serum Kisspeptin levels and the prevalence of insulin resistance in PCOS patients', 'timeFrame': '40 weeks', 'description': 'The predictive value of serum Kisspeptin levels in the first trimester for insulin resistance in PCOS patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polycystic Ovary Syndrome', 'Pregnancy Complications', 'Kisspeptin', 'gestational diabetes mellitus', 'insulin resistance'], 'conditions': ['Polycystic Ovary Syndrome', 'Pregnancy Complications']}, 'descriptionModule': {'briefSummary': 'The current study aims to investigate the dynamic serum kisspeptin levels throughout pregnancy and to explore its predictive value for GDM in PCOS.', 'detailedDescription': 'The current prospective cohort study aims to investigate the dynamic serum kisspeptin levels in the patients with polycystic ovary syndrome (PCOS) at different trimesters of pregnancy, to analyze the associations between serum kisspeptin, insulin, glucose and testosterone, and to explore the predictive value of kisspeptin for GDM and other complications in PCOS patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The characteristics of patients with polycystic ovary syndrome include amenorrhea or infrequent menstruation, high hormone levels, and polycystic ovary like changes in the ovaries. Usually accompanied by fertility disorders and metabolic disorders, PCOS patients face a higher risk of pregnancy complications during pregnancy.', 'genderDescription': 'Positive pregnancy test and confirmed intrauterine singleton pregnancy by ultrasound', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 40 years old\n* Women diagnosed as PCOS who register for prenatal check ups in the obstetrics outpatient department of hospitals during early pregnancy.(The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria (any two out of the three key characteristics of PCOS: oligo-amenorrhea, hyperandrogenism, and polycystic-appearing ovarian morphology on ultrasonography) .\n\nExclusion Criteria:\n\n* All other diseases with ovulation disorders or hyperandrogenism'}, 'identificationModule': {'nctId': 'NCT06545994', 'briefTitle': 'A Prospective Cohort Study on the Serum Kisspeptin Levels Throughout Pregnancy in PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective Cohort Study on the Dynamic Monitoring of Serum Kisspeptin Levels Throughout Pregnancy and Exploring Its Predictive Value for Gestational Diabetes Mellitus in PCOS Patients', 'orgStudyIdInfo': {'id': 'FudanU2024-04-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PCOS group', 'description': 'Pregnant women between 18 and 40 years old who were diagnosed as polycystic ovary syndrome before pregnancy, registered in the OB \\& GYN Hospital of Fudan University for prenatal check during the first trimester. The diagnostic criteria for PCOS are based on the 2003 Rotterdam diagnostic criteria.\n\nExclude healthy women with all other diseases that may have ovulation disorders or hyperandrogenism; There are other serious illnesses or complications present; Other endocrine disorders exist: thyroid diseases such as hyperthyroidism or hypothyroidism; During pregnancy, medication that may affect Kisspeptin or insulin levels, such as metformin or insulin therapy, is being used;', 'interventionNames': ['Other: Observation']}, {'label': 'Control group', 'description': 'Healthy pregnant women between 18 and 40 years old women without a history of PCOS.\n\nExclude healthy women with all other diseases that may have ovulation disorders or hyperandrogenism; There are other serious illnesses or complications present; Other endocrine disorders exist: thyroid diseases such as hyperthyroidism or hypothyroidism; During pregnancy, medication that may affect Kisspeptin or insulin levels, such as metformin or insulin therapy, is being used;'}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': "It's a observational cohort study and no interventions are performed.", 'armGroupLabels': ['PCOS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hexia Xia, M.D.', 'role': 'CONTACT', 'phone': '+8613601843476'}], 'facility': 'OB & GYN Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Wei Zhang, phD', 'role': 'CONTACT', 'email': 'zhangwei623@hotmail.com', 'phone': '+8613611691036'}], 'overallOfficials': [{'name': 'Hexia Xia, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Obstetrics & Gynecology Hospital of Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Ph.D', 'investigatorFullName': 'Zhang Wei', 'investigatorAffiliation': 'Fudan University'}}}}