Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-01-02 @ 8:55 AM
Study NCT ID:
NCT03833869
Status:
UNKNOWN
Last Update Posted:
2019-06-11
First Post:
2019-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assisted Hatching in Frozen Blastocysts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2019-02-06', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': 'Five to six weeks following embryo transfer', 'description': 'Number of gestational sacs demonstrated on ultrasound divided by the number of embryos transferred (expressed as percentage)'}], 'secondaryOutcomes': [{'measure': 'Chemical pregnancy', 'timeFrame': 'Five to six weeks following embryo transfer', 'description': 'Increase and subsequent decrease in beta HCG levels with no evidence of gestational sac on ultrasound'}, {'measure': 'Early spontaneous abortion', 'timeFrame': 'Up to 15 weeks from embryo transfer', 'description': 'Spontaneous abortion of pregnancy during the first trimester of pregnancy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ART']}, 'descriptionModule': {'briefSummary': 'The current study aims to assess the effect of assisted hatching on the implantation rate of frozen blastocytes.', 'detailedDescription': 'The Zona Pellucida protects the ovum from the penetration of multiple sperm, and from mechanical and physiological damage until the fertilized ovum reaches the uterus. Subsequently, spontaneous hatching occurs, and enables the embryo to attach to the endometrium. The technique of assisted hatching was originally investigated as a means to improve implantation in cases of zona hardening, and is commonly performed in 3-day embryos. In the current study, the investigators aim to investigate the effect of assisted hatching on 5-day frozen embryos.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* In-vitro fertilization patients at the investigators' institution, intended to undergo a transfer of a frozen five-day embryo (blastocyte)\n* 18 to 39 years old\n* First to third treatment cycle\n* Patient has previously had a maximum of four embryos transferred.\n\nExclusion Criteria:\n\n* Over 40 years old\n* Congenital or acquired uterine malformations\n* Hydrosalpinx\n* Chronic autoimmune diseases\n* Embryo intended to be undergo preimplantation genetic diagnosis"}, 'identificationModule': {'nctId': 'NCT03833869', 'briefTitle': 'Assisted Hatching in Frozen Blastocysts', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'The Effect of Assisted Hatching on Implantation Rate in Frozen Blastocyst Transfer - a Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': '0020-19-WOMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Assisted hatching', 'description': 'Five-day frozen embryos will undergo assisted hatching prior to embryo transfer', 'interventionNames': ['Procedure: Assisted hatching']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Five-day frozen embryos will not undergo any additional procedures prior to embryo transfer'}], 'interventions': [{'name': 'Assisted hatching', 'type': 'PROCEDURE', 'description': 'Controlled hatching of the zona pellucida in the laboratory prior to embryo transfer', 'armGroupLabels': ['Assisted hatching']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Holon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Hadas Ganer Herman, MD', 'role': 'CONTACT'}], 'facility': 'Edith Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'centralContacts': [{'name': 'Hadas Ganer Herman, MD', 'role': 'CONTACT', 'email': 'hadassganer@yahoo.com', 'phone': '9720526206696'}], 'overallOfficials': [{'name': 'Hadas Ganer Herman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edith Wolfson Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hadas Ganer Herman', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}