Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-04-05 @ 5:48 AM
Study NCT ID:
NCT03660904
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2018-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020964', 'term': 'Embryo Loss'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'only the investigator knew the procedure and the media provided for each case'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1 blastocysts were vitrified with the Vit (home made) HM according to shady grove protocol using open system on cryotop vit. device and thawed with gradual thawing technique using HM thawing media according to Kuwayama protocol.\n\nGroup 2 blastocysts were cryopreserved with the Global Fast Freeze Kit using open system on cryotop vit. device and thawed using Global fast thaw kit. Blastocysts were assessed immediately for survival, subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-06', 'studyFirstSubmitDate': '2018-09-02', 'studyFirstSubmitQcDate': '2018-09-06', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blastocyst immediate survival', 'timeFrame': '0 hour at time of thawing', 'description': 'The effect of Vitrification protocol on the blastocyst immediate survival'}], 'secondaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '2 weeks after transfer', 'description': 'clinical pregnancy rate in these cases'}, {'measure': 'live birth rate', 'timeFrame': '9 months', 'description': 'live birth rate of positive pregnancy cases'}, {'measure': 'Blastocyst survival at 6 hours', 'timeFrame': '6 hours after thawing', 'description': 'The effect of Vitrification protocol on the blastocyst survival after 6 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitrification', 'blastocysts', 'home-made media'], 'conditions': ['Blastocyst Disintegration']}, 'descriptionModule': {'briefSummary': 'This study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).', 'detailedDescription': 'Group 1 blastocysts were vitrified with the Vit HM according to shady grove protocol using open system on cryotopvit. device and thawed with gradual thawing technique using HM according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kitusing open system on cryotopvit. device and thawed using Gobal fast thaw kit. Blastocysts were subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '22 Years', 'genderBased': True, 'genderDescription': 'blastocysts of infertile couples', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of the patients 22-37\n* All vitrified \\& thawed blastocyst.\n* unexplained cases or ovarian factors for infertility.\n\nExclusion Criteria:\n\n* extremes of age\n* cases of uterine factor\n* endometriosis'}, 'identificationModule': {'nctId': 'NCT03660904', 'briefTitle': 'A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst Survival, Expansion and Implantation', 'orgStudyIdInfo': {'id': 'Hawaa-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home made media', 'description': 'home made vitrification \\& thawing kit', 'interventionNames': ['Biological: home made vitrification & thawing kit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial media', 'description': 'commercially available vitrification \\& thawing kit', 'interventionNames': ['Biological: commercially made vitrification & thawing kit']}], 'interventions': [{'name': 'home made vitrification & thawing kit', 'type': 'BIOLOGICAL', 'description': 'home made vitrification was made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too', 'armGroupLabels': ['Home made media']}, {'name': 'commercially made vitrification & thawing kit', 'type': 'BIOLOGICAL', 'description': 'commercially available vitrification \\& thawing kit were made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too', 'armGroupLabels': ['Commercial media']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Ob. & Gyn.', 'investigatorFullName': 'Ahmed Saad', 'investigatorAffiliation': 'Benha University'}}}}