Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT05545995
Status:
UNKNOWN
Last Update Posted:
2022-09-28
First Post:
2022-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D000782', 'term': 'Aneuploidy'}, {'id': 'D002869', 'term': 'Chromosome Aberrations'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-09-15', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Embryotransfers to conceive', 'timeFrame': 'Up to the embryotransfer of the last enrolled patient (Dec 2023)', 'description': 'The number of the embryotransfers required for women to conceive'}, {'measure': 'Time interval to conceive', 'timeFrame': 'Up to the pregnancy test after the last embryo transfer of an enrolled patient (Jan 2024)', 'description': 'Time interval required for women to conceive (in months): from OPU day to positive hCG test'}, {'measure': 'Cumulative Live Birth Rate', 'timeFrame': 'Up to 38 weeks after the embryo transfer', 'description': 'Cumulative Live Birth Rate achieved after one OPU treatment'}], 'secondaryOutcomes': [{'measure': 'Abortion rate', 'timeFrame': 'Up to 2nd trimester miscarriages', 'description': 'The spontaneous miscarriage of women in both groups'}, {'measure': 'DaC rate', 'timeFrame': 'Up to 24 weeks of pregnancy according to Greek Law', 'description': 'The rate of the dilation and curretage rate in both groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IVF', 'PGT-A', 'NON- INVASIVE PGT-A', 'TIME LAPSE', 'EMBRYO SELECTION'], 'conditions': ['Infertility', 'Aneuploidy', 'Chromosome Abnormality']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomised study of the evaluation of the clinical IVF results after time lapse assisted embryo selection versus Non-invasive PGT-A assisted embryo selection in subfertile women.', 'detailedDescription': 'A randomized prospective study focusing on subfertile women undergoing IVF treatment followed by embryo transfer on the blastocyst stage.\n\nWomen assigned to group A proceed to embryo transfer, after time lapse assisted embryo selection, while women of group B after non-invasive PGT-A assisted embryo selection.\n\nIVF outcomes, regarding the success rate of the trasnfer and the time required to achieve conception is studied in both groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women aged 18- 39, faced with infertility issues, meeting the above inclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who followed IVF treatment\n* 39 years old or younger\n* Single embryo transfer\n* blastocyst stage cultured embryos\n\nExclusion Criteria:\n\n* women over the age of 39 years\n* not blastocyst transfer (transfers performed at earlier embryo stage)\n* double embryotransfer\n* women who had invasive PGT-a test\n* women whose embryos were not time-lapse monitored'}, 'identificationModule': {'nctId': 'NCT05545995', 'briefTitle': 'Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection', 'organization': {'class': 'OTHER', 'fullName': 'Assisting Nature'}, 'officialTitle': 'IVF Outcomes Based on Time Lapse Assisted Embryo Selection Versus Non Invasive PGT-A Assisted Embryo Selection', 'orgStudyIdInfo': {'id': 'AN009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TIME LAPSE', 'description': 'Women who proceed to embryo transfer after time lapse assisted embryo selection.', 'interventionNames': ['Other: embryo selection']}, {'label': 'NI-PGT-A', 'description': 'Women who proceed to embryo transfer after non-invasive PGT-A assisted embryo selection.', 'interventionNames': ['Other: embryo selection']}], 'interventions': [{'name': 'embryo selection', 'type': 'OTHER', 'description': 'The basis of embryo seletion for transfer: morphological or genetic after non-invasive PGT-A', 'armGroupLabels': ['NI-PGT-A', 'TIME LAPSE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57001', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Evaggelos Papanikolaou, MD, PhD', 'role': 'CONTACT', 'email': 'embryology@assistingnature.gr', 'phone': '00302310424294'}, {'name': 'Maria Galiotou, MSc', 'role': 'CONTACT', 'email': 'galiotou@assistingnature.gr', 'phone': '00302310424294'}], 'facility': 'Assisting Nature', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Evangelos Papanikolaou, MD,PhD', 'role': 'CONTACT', 'email': 'drvagpapanikolaou@yahoo.gr', 'phone': '00302310424294'}, {'name': 'Maria Galiotou, MSc', 'role': 'CONTACT', 'email': 'galiotou@assistingnature.gr', 'phone': '00302310424294'}], 'overallOfficials': [{'name': 'Evangelos Papanikolaou, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assisting Nature'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assisting Nature', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic', 'investigatorFullName': 'Papanikolaou Evaggelos', 'investigatorAffiliation': 'Assisting Nature'}}}}