Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-31 @ 3:36 PM
Study NCT ID:
NCT04310761
Status:
COMPLETED
Last Update Posted:
2020-03-17
First Post:
2020-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Comparison of Pregnancy Outcome of Infertile Patients After Fresh and Warmed Single Blastocyst Transfer From 2014 to 2018.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4613}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-13', 'studyFirstSubmitDate': '2020-03-13', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of live births', 'timeFrame': '5 years', 'description': 'Rate of live births with the relative gestational period and neonatal weight and still death and neonatal death per each single blastocyst transfer, both fresh and warmed'}], 'secondaryOutcomes': [{'measure': 'Incidence of obstetric pathologies', 'timeFrame': '5 years', 'description': 'Incidence of obstetric pathologies, gestational diabetes and pre-eclampsia, and defects of placentation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Maternal and Neonatal Outcomes; Assisted Reproductive Technology']}, 'referencesModule': {'references': [{'pmid': '30458993', 'type': 'BACKGROUND', 'citation': 'Zhang J, Wang Y, Liu H, Mao X, Chen Q, Fan Y, Xiao Y, Kuang Y. Effect of in vitro culture period on birth weight after vitrified-warmed transfer cycles: analysis of 4,201 singleton newborns. Fertil Steril. 2019 Jan;111(1):97-104. doi: 10.1016/j.fertnstert.2018.10.006. Epub 2018 Nov 17.'}, {'pmid': '24268706', 'type': 'BACKGROUND', 'citation': 'Ishihara O, Araki R, Kuwahara A, Itakura A, Saito H, Adamson GD. Impact of frozen-thawed single-blastocyst transfer on maternal and neonatal outcome: an analysis of 277,042 single-embryo transfer cycles from 2008 to 2010 in Japan. Fertil Steril. 2014 Jan;101(1):128-33. doi: 10.1016/j.fertnstert.2013.09.025. Epub 2013 Oct 23.'}, {'pmid': '29331236', 'type': 'BACKGROUND', 'citation': 'Sha T, Yin X, Cheng W, Massey IY. Pregnancy-related complications and perinatal outcomes resulting from transfer of cryopreserved versus fresh embryos in vitro fertilization: a meta-analysis. Fertil Steril. 2018 Feb;109(2):330-342.e9. doi: 10.1016/j.fertnstert.2017.10.019. Epub 2018 Jan 11.'}, {'pmid': '34837160', 'type': 'DERIVED', 'citation': 'Cirillo F, Grilli L, Ronchetti C, Paladino I, Morenghi E, Busnelli A, Levi-Setti PE. Retrospective comparison of pregnancy outcomes of fresh and frozen-warmed single blastocyst transfer: a 5-year single-center experience. J Assist Reprod Genet. 2022 Jan;39(1):201-209. doi: 10.1007/s10815-021-02362-3. Epub 2021 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'The investigators retrospectively analysed the maternal and neonatal outcomes following a single fresh blastocyst transfer and a single warmed blastocyst transfer from procedures performed between 2014 and 2018 in a tertiary level university based fertility clinic.', 'detailedDescription': 'Previous studies that analysed pregnancy outcomes in women who underwent frozen single blastocyst transfer have shown an increase rate of large for gestational age and very large for gestational age (Zhang et al., 2019),increased maternal risks of placenta accreta and pregnancy-induced hypertension (Ishihara et al.,2014),and lower risks of placenta previa, placental abruption, very pre-term birth, small for gestational age, and perinatal mortality (Sha, Yin, Cheng,\\& Massey, 2018) than fresh blastocyst transfer.\n\nThe main outcome of this study is to analyse the rate of live births with the relative gestational period and neonatal weight and still death and neonatal death per each single blastocyst transfer, both fresh and warmed. Secondary outcomes include the incidence of obstetric pathologies, gestational diabetes and pre-eclampsia, and defects of placentation.\n\nThe study database included all pregnancies occurred after both a single fresh and warmed blastocyst transfer between the five-year period from 2014 to 2018 at Humanitas Fertility Centre. The inclusion criteria were all patients, without any age limitations, which underwent either FIVET or ICSI and only transferred a single blastocyst. With regards to exclusion criteria, the following were considered: ovodonation, suspended cycles and embryos which were subjected to pre-implantation genetic testing.The investigator performed a comparison of maternal and neonatal outcomes in these pregnancies which occurred in the same period of time and in the same age-group of women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All infertile patients which performed a single fresh and a single frozen embryo transfer from 2014 to 2018.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile women, without any age limitations, which underwent either FIVET or ICSI and only transferred a single blastocyst (warmed or fresh).\n\nExclusion Criteria:\n\n* Ovodonation, suspended cycles, and embryos subjected to pre-implantation genetic testing.'}, 'identificationModule': {'nctId': 'NCT04310761', 'briefTitle': 'Retrospective Comparison of Pregnancy Outcome of Infertile Patients After Fresh and Warmed Single Blastocyst Transfer From 2014 to 2018.', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Retrospective Comparison of Pregnancy Outcome of Infertile Patients After Fresh and Warmed Single Blastocyst Transfer From 2014 to 2018.', 'orgStudyIdInfo': {'id': 'XX/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pregnancy population after one single blastocyst transfer', 'description': "The data have been collected from the Humanitas Fertility Center' Department database (ART.it) from a period between 2014 and 2018.", 'interventionNames': ['Procedure: one single blastocyst transfer, both fresh and warmed']}], 'interventions': [{'name': 'one single blastocyst transfer, both fresh and warmed', 'type': 'PROCEDURE', 'description': 'Ultrasound guided transvaginal embryo transfer.', 'armGroupLabels': ['pregnancy population after one single blastocyst transfer']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}