Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-27 @ 6:43 AM
Study NCT ID:
NCT06581692
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Monitoring of Miscarriage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood, Products of conception'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2039-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-11', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-08-30', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cell-free DNA (cfDNA)', 'timeFrame': '15 weeks', 'description': 'Determine the use of cfDNA to ascertain chromosomal causes of miscarriages'}], 'secondaryOutcomes': [{'measure': 'Level of cell-free DNA', 'timeFrame': '15 weeks', 'description': 'To determine the level of cell-free DNA (cfDNA) in early pregnancy'}, {'measure': 'Aneuploidy results from product of conception', 'timeFrame': '15 weeks', 'description': 'To compare the aneuploidy results from product of conception (POC), in concordance with standard karyotyping.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Miscarriage in First Trimester']}, 'descriptionModule': {'briefSummary': 'cfDNA is extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.', 'detailedDescription': 'Pregnancies achieved by assisted reproductive technologies (ART) are closely monitored, therefore miscarriages that occur very early in the pregnancy are frequently meticulously recorded and reported. On the other hand, spontaneous abortion rates among naturally occurring conceptions are notoriously hard to quantify and are often overstated when using criteria from assisted reproductive technologies. Additionally, women who have undergone treatment with ART are a particular population with traits that can make them more vulnerable to spontaneous abortions.\n\ncfDNA would be extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be approached on the day of attending the early pregnancy loss clinic, and given information about the study. Sufficient time will be allowed for consideration before they confirm their decision and sign the consent. For cases with the management of ultrasound-guided manual vacuum aspiration (USG-MVA) or surgical evacuation, their remaining products of gestation will be collected for analysis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-45 years.\n2. Women who attend the early pregnancy loss clinic or Patients who receive ART\n3. Their partner, the biological father of the pregnancy\n\nExclusion Criteria:\n\n* History of psychological/ psychiatric problem\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT06581692', 'briefTitle': 'Non-invasive Monitoring of Miscarriage', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Non-invasive Monitoring of Miscarriage', 'orgStudyIdInfo': {'id': '2024.354'}}, 'armsInterventionsModule': {'interventions': [{'name': 'This is a routine procedure, no intervention will be provided.', 'type': 'OTHER', 'description': 'This is a routine procedure, no intervention will be provided.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Jacqueline Pui Wah CHUNG, MBBS', 'role': 'CONTACT', 'email': 'jacquelinechung@cuhk.edu.hk', 'phone': '30501537'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'PUI WAH JACQUELINE CHUNG', 'role': 'CONTACT', 'email': 'jacquelinechung@cuhk.edu.hk', 'phone': '+852 35051764'}, {'name': 'Yee Lee Elaine NG', 'role': 'CONTACT', 'email': 'elaineng@cuhk.edu.hk', 'phone': '+852 35052745'}], 'overallOfficials': [{'name': 'PUI WAH JACQUELINE CHUNG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chung Pui Wah Jacqueline', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}