Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-24 @ 6:39 PM
Study NCT ID:
NCT04280757
Status:
UNKNOWN
Last Update Posted:
2023-10-13
First Post:
2020-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Biopsied and Non-biopsied Intracytoplasmatic Sperm Injection (ICSI) Embryos and Natural Pregnancy Embryos
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010715', 'term': 'Phosphatidylglycerols'}], 'ancestors': [{'id': 'D020404', 'term': 'Glycerophospholipids'}, {'id': 'D010712', 'term': 'Phosphatidic Acids'}, {'id': 'D005994', 'term': 'Glycerophosphates'}, {'id': 'D010743', 'term': 'Phospholipids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-12', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First primary endpoint', 'timeFrame': 'At pregnancy', 'description': '\\- Early ultrasound measurements "yolk sac (YS), mean sac diameter (MSD), crown rump length (CRL)", different maternal serum prenatal screening markers for growth and aneuploidy between the three arms\\* of the study'}, {'measure': 'Second primary endpoint', 'timeFrame': 'At 2nd trimester of pregnancy', 'description': '\\- Second trimetric U/S measurements of fetal growth : U/S measurements of fetal growth using growth curves and measurement of FPI (fetal ponderal index) and fetal weight percentile'}, {'measure': 'Third primary endpoint', 'timeFrame': 'At 3rd trimester of pregnancy', 'description': '\\- Third-trimester U/S measurements of fetal growth : U/S measurements of fetal growth using growth curves and measurement of FPI (fetal ponderal index) and fetal weight percentile'}], 'secondaryOutcomes': [{'measure': 'First secondary endpoint', 'timeFrame': 'At Labor', 'description': 'Miscarriage'}, {'measure': 'Second secondary endpoint', 'timeFrame': 'At Labor', 'description': 'Live-birth weight'}, {'measure': 'Third secondary endpoint', 'timeFrame': 'At Labor', 'description': 'Preterm labor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fetal growth', 'biochemical parameters'], 'conditions': ['Women Conceiving by: 1- ICSI-PGS 2- ICSI-non-PGS 3- Spontaneously Conceiving Women']}, 'descriptionModule': {'briefSummary': "As Pre Implantation Genetic Screening (PGS) becomes now a replacement modality and trend gaining popularity among physicians and patients on claiming its ability to settle on the simplest genetically normal embryo, so it had been logical to review if taking cells from the embryo in its early development will or won't affect its growth as compared to the previous standard technique of ICSI and in comparison to a normally conceived embryos the study also will question if the parameters of the prenatal biochemical standard parameters will have any differences if the embryo is already genetically tested embryo and compare these parameters with non PGS embryos and normally conceived embryos.\n\nThis study is an ambispective, comparative, cohort, observational, single-center study.\n\nThe study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms", 'detailedDescription': "This study is an ambispective, comparative, cohort, observational, single-center study that will be conducted at Wael ElBanna Clinic, a private center that is well equipped for all procedures needed for ICSI and fetal medicine. After obtaining informed consent, the study participants' relevant medical records will be collected and reviewed. Data will be collected from the subjects' medical records. Data will be pooled and presented in aggregate, without identification of individual subjects.\n\nThe study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:\n\n* Arm 1: biopsied ICSI embryos (PGS)\n* Arm 2: none biopsied ICSI embryos\n* Arm 3: natural pregnancy embryos"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population include women conceiving by:\n\n1. ICSI-PGS\n2. ICSI-non-PGS\n3. Spontaneously conceiving women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Singleton pregnant women\n2. Pregnancy confirmation by ultrasound at week 6 of gestation either by normal pregnancy or ICSI (Biopsied and Non-Biopsied)\n3. Between the age of 20 and 40 years.\n4. Non-smokers.\n5. BMI must be between 19 and 40\n\nExclusion Criteria:\n\n1. Those with anti-phospholipid syndrome confirmed by serological tests\n2. Those with any hematological and immunological disorders\n3. Women with uterine abnormalities have not been corrected.\n4. Women with systemic diseases that cannot be controlled or managed'}, 'identificationModule': {'nctId': 'NCT04280757', 'acronym': 'BNB-ICSI', 'briefTitle': 'Comparison Between Biopsied and Non-biopsied Intracytoplasmatic Sperm Injection (ICSI) Embryos and Natural Pregnancy Embryos', 'organization': {'class': 'OTHER', 'fullName': 'Wael Elbanna Clinic'}, 'officialTitle': 'Ambispective Comparative Cohort Study to Assess the Differences in Development and Growth Patterns of Biopsied and Non-Biopsied ICSI Embryos and Natural Pregnancy Embryos[BNB-ICSI Study]', 'orgStudyIdInfo': {'id': 'Elbanna_2020_02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'description': 'Biopsied ICSI embryos', 'interventionNames': ['Procedure: Biopsied ICSI embryos (PGS)']}, {'label': 'Arm 2', 'description': 'Non biopsied ICSI embryos'}, {'label': 'Arm 3', 'description': 'Natural pregnancy embryos'}], 'interventions': [{'name': 'Biopsied ICSI embryos (PGS)', 'type': 'PROCEDURE', 'description': 'Biopsied ICSI embryos (PGS)', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'wael Elbanna, specialist', 'role': 'CONTACT', 'email': 'waelelbanna@drwaelelbanna.com', 'phone': '00201227760402'}], 'facility': 'wael Elbanna Clinic', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'wael Elbanna, Specialist', 'role': 'CONTACT', 'email': 'waelelbanna@drwaelelbanna.com', 'phone': '00201227760402'}], 'overallOfficials': [{'name': 'Wael Elbanna, Specialist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wael Elbanna Clinic'}, {'name': 'Eduard Gratacos, Specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'fetal medicine'}, {'name': 'Manal El-Hinnawi, Specialist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wael Elbanna Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wael Elbanna Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fetal Medicine Research Center, Spain', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'European board fellow of obstetrics and gynecology', 'investigatorFullName': 'Wael Elbanna', 'investigatorAffiliation': 'Wael Elbanna Clinic'}}}}