Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-02 @ 6:08 AM
Study NCT ID:
NCT02048527
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2014-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-15', 'studyFirstSubmitDate': '2014-01-27', 'studyFirstSubmitQcDate': '2014-01-27', 'lastUpdatePostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implantation rate per embryo transferred', 'timeFrame': '7 weeks', 'description': 'Number of fetal sacs with positive heart beat at 7 weeks of gestation'}], 'secondaryOutcomes': [{'measure': 'Blastocyst formation rate', 'timeFrame': 'Day 5', 'description': 'Embryos reaching the blastocyst stage on Day 5 post oocyte retrieval'}, {'measure': 'Good quality blastocysts', 'timeFrame': 'Day 5', 'description': 'Good quality blastocysts are considered at least full blastocysts (stage 3 and above) with grade A or grade B inner-cell mass and trophectoderm respectively.'}, {'measure': 'Positive hCG rates', 'timeFrame': '14 days', 'description': 'Pregnancy test as assessed by detection of hCG using blood test'}, {'measure': 'Ongoing pregnancy rates', 'timeFrame': '12 weeks', 'description': 'Pregnancy reaching 12 weeks of gestation'}, {'measure': 'Early pregnancy loss', 'timeFrame': '12 weeks', 'description': 'Miscarriage per positive hCG test up to 12 weeks of gestation'}, {'measure': 'Clinical pregnancy', 'timeFrame': '7 weeks', 'description': 'Pregnancy reaching 7 weeks of gestation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '18439587', 'type': 'BACKGROUND', 'citation': 'Sepulveda S, Garcia J, Arriaga E, Diaz J, Noriega-Portella L, Noriega-Hoces L. In vitro development and pregnancy outcomes for human embryos cultured in either a single medium or in a sequential media system. Fertil Steril. 2009 May;91(5):1765-70. doi: 10.1016/j.fertnstert.2008.02.169. Epub 2008 Apr 25.'}, {'pmid': '23315059', 'type': 'BACKGROUND', 'citation': 'Basile N, Morbeck D, Garcia-Velasco J, Bronet F, Meseguer M. Type of culture media does not affect embryo kinetics: a time-lapse analysis of sibling oocytes. Hum Reprod. 2013 Mar;28(3):634-41. doi: 10.1093/humrep/des462. Epub 2013 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.', 'detailedDescription': 'Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.\n\nThe current study will include 2 RCTs:\n\nRCT 1: Random allocation of sibling oocytes to compare embryo development and blastocyst formation rates in the two culture media compared.\n\nRCT2: Random allocation of patients in either Global or Origio media, to evaluate pregnancy rates.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<40 years of age\n* female infertility patients\n* at least 10 retrieved oocytes\n\nExclusion Criteria:\n\n* 41 years or older\n* frozen-thawed oocytes/embryos\n* oocyte donation cycles'}, 'identificationModule': {'nctId': 'NCT02048527', 'briefTitle': 'Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates', 'organization': {'class': 'OTHER', 'fullName': 'Eugonia'}, 'officialTitle': 'Comparison of Single-step (Global) Versus Sequential Media (Origio) in Preimplantation Embryo Development and Pregnancy Rates', 'orgStudyIdInfo': {'id': 'Global versus Origio'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Global', 'description': 'In vitro embryo culture in single-step medium (Global)', 'interventionNames': ['Other: Global']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Origio', 'description': 'In vitro embryo culture in sequential media (Origio)', 'interventionNames': ['Other: Origio']}], 'interventions': [{'name': 'Global', 'type': 'OTHER', 'otherNames': ['Global medium (LIfeGlobal)'], 'description': 'Single medium for the culture of embryos from Day1 to Day 5', 'armGroupLabels': ['Global']}, {'name': 'Origio', 'type': 'OTHER', 'otherNames': ['ISM1/BlastAssist (Origio)'], 'description': 'Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)', 'armGroupLabels': ['Origio']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Eugonia Assisted Reproduction Unit', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Ioannis A Sfontouris, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eugonia'}, {'name': 'Trifon G Lainas, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eugonia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eugonia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}