Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:55 AM
Study NCT ID:
NCT07349966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Trophectoderm (TE) Biopsy on the Health and Development of Children Born After Preimplantation Genetic Testing (PGT) Cycles.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-10-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Objectives: Health and development of children at the first and fifth years of life.', 'timeFrame': 'At 12 and at 60 months of age', 'description': 'Questionnaire'}], 'primaryOutcomes': [{'measure': 'Impact of Blastocyst Biopsy on Postnatal Growth at One Year', 'timeFrame': '12 months of life of children', 'description': 'Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Long-Term Growth After Blastocyst Biopsy', 'timeFrame': 'At birth of children and at 60 months of age', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ART', 'PGT', 'FET'], 'conditions': ['Preimplantation Genetic Testing (PGT)', 'Frozen Embryo Transfer Cycle', 'Assisted Reproduction Technologies', 'Postnatal Health']}, 'referencesModule': {'references': [{'pmid': '35219589', 'type': 'BACKGROUND', 'citation': 'Alteri A, Campo G, Pagliardini L, Privitera L, Cavoretto PI, Candiani M, Papaleo E, Vigano P. The effect of vitrified-warmed blastocyst transfer on postnatal growth: a 1-year follow-up questionnaire study. Reprod Biomed Online. 2022 May;44(5):907-914. doi: 10.1016/j.rbmo.2021.12.018. Epub 2022 Jan 16.'}, {'pmid': '36655536', 'type': 'BACKGROUND', 'citation': 'Alteri A, Cermisoni GC, Pozzoni M, Gaeta G, Cavoretto PI, Vigano P. Obstetric, neonatal, and child health outcomes following embryo biopsy for preimplantation genetic testing. Hum Reprod Update. 2023 May 2;29(3):291-306. doi: 10.1093/humupd/dmad001.'}, {'pmid': '25046131', 'type': 'BACKGROUND', 'citation': 'von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.'}, {'pmid': '34373103', 'type': 'BACKGROUND', 'citation': 'Hou W, Shi G, Ma Y, Liu Y, Lu M, Fan X, Sun Y. Impact of preimplantation genetic testing on obstetric and neonatal outcomes: a systematic review and meta-analysis. Fertil Steril. 2021 Oct;116(4):990-1000. doi: 10.1016/j.fertnstert.2021.06.040. Epub 2021 Aug 7.'}, {'pmid': '27063603', 'type': 'BACKGROUND', 'citation': 'Magnus P, Birke C, Vejrup K, Haugan A, Alsaker E, Daltveit AK, Handal M, Haugen M, Hoiseth G, Knudsen GP, Paltiel L, Schreuder P, Tambs K, Vold L, Stoltenberg C. Cohort Profile Update: The Norwegian Mother and Child Cohort Study (MoBa). Int J Epidemiol. 2016 Apr;45(2):382-8. doi: 10.1093/ije/dyw029. Epub 2016 Apr 10.'}, {'pmid': '32851407', 'type': 'BACKGROUND', 'citation': 'Ong YY, Sadananthan SA, Aris IM, Tint MT, Yuan WL, Huang JY, Chan YH, Ng S, Loy SL, Velan SS, Fortier MV, Godfrey KM, Shek L, Tan KH, Gluckman PD, Yap F, Choo JTL, Ling LH, Tan K, Chen L, Karnani N, Chong YS, Eriksson JG, Wlodek ME, Chan SY, Lee YS, Michael N. Mismatch between poor fetal growth and rapid postnatal weight gain in the first 2 years of life is associated with higher blood pressure and insulin resistance without increased adiposity in childhood: the GUSTO cohort study. Int J Epidemiol. 2020 Oct 1;49(5):1591-1603. doi: 10.1093/ije/dyaa143. Erratum In: Int J Epidemiol. 2021 May 17;50(2):702. doi: 10.1093/ije/dyab005.'}, {'pmid': '30258309', 'type': 'BACKGROUND', 'citation': 'Waynforth D. Effects of Conception Using Assisted Reproductive Technologies on Infant Health and Development: An Evolutionary Perspective and Analysis Using UK Millennium Cohort Data. Yale J Biol Med. 2018 Sep 21;91(3):225-235. eCollection 2018 Sep.'}, {'pmid': '34473268', 'type': 'BACKGROUND', 'citation': 'Zheng W, Yang C, Yang S, Sun S, Mu M, Rao M, Zu R, Yan J, Ren B, Yang R, Guan Y. Obstetric and neonatal outcomes of pregnancies resulting from preimplantation genetic testing: a systematic review and meta-analysis. Hum Reprod Update. 2021 Oct 18;27(6):989-1012. doi: 10.1093/humupd/dmab027.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effects of trophectoderm (TE) biopsy on the health and development of children born after preimplantation genetic testing (PGT) cycles. The blastocyst biopsy is performed as part of standard clinical practice, in accordance with established protocols and current national regulations governing assisted reproduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will involve a total of 330 children born as single live births after their mothers underwent assisted reproduction technology (ART) treatment. The participant population includes:\n\n* Cases: 110 children born as single live births after their mothers underwent a PGT cycle followed by frozen embryo transfer (FET).\n* Controls: 220 children born as single live births after their mothers underwent only FET.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Cases:\n\n* Child: Has completed the first year of life at the time of data collection.\n* Child: Does not have any pre-existing medical conditions that significantly affect growth (weight and height).\n* Mother: Able to provide informed consent for participation in the study.\n* Mother: Conceived between the ages of 18 and 43.\n* Mother: Achieved a singleton live birth with a single gestational sac.\n* Mother: Underwent a PGT cycle followed by FET.\n\nInclusion Criteria for Controls:\n\n* Child: Has completed the first year of life at the time of data collection.\n* Child: Does not have any pre-existing medical conditions that significantly affect growth (weight and height).\n* Mother: Able to provide informed consent for participation in the study.\n* Mother: Conceived between the ages of 18 and 43.\n* Mother: Achieved a singleton live birth with a single gestational sac.\n* Mother: Underwent only FET.\n\nParticipants will be excluded from this study if they meet any of the following criteria:\n\n* Mother: Unable or unwilling to sign the informed consent.\n* Mother: Has undergone a fresh embryo transfer.\n* Child: Missing birth weight or length/height data.'}, 'identificationModule': {'nctId': 'NCT07349966', 'briefTitle': 'Effects of Trophectoderm (TE) Biopsy on the Health and Development of Children Born After Preimplantation Genetic Testing (PGT) Cycles.', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'A Prospective Observational Study of the Impact of Blastocyst Biopsy on Postnatal Growth in Children Born After Preimplantation Genetic Testing', 'orgStudyIdInfo': {'id': 'BABYPGT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': '110 children born as single live births after their mothers underwent a PGT cycle followed by frozen embryo transfer (FET).', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Controls', 'description': '220 children born as single live births after their mothers underwent only FET.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'The only additional procedure involved in this study is the administration of a questionnaire to the parents, which is not part of routine clinical follow-up. The questionnaire was originally developed in the context of the Norwegian Mother and Child Cohort Study (MoBa).', 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Milano', 'country': 'Italy', 'contacts': [{'name': 'Luca Pagliardini, PhD', 'role': 'CONTACT', 'email': 'pagliardini.luca@hsr.it', 'phone': '0226434834', 'phoneExt': '0039'}, {'name': 'ENRICO PAPALEO, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Irccs San Raffaele Hospital', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'LUCA PAGLIARDINI, PhD', 'role': 'CONTACT', 'email': 'pagliardini.luca@hsr.it', 'phone': '0226434834', 'phoneExt': '0039'}], 'overallOfficials': [{'name': 'ENRICO PAPALEO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Enrico Papaleo', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}