Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT03823235
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2019-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Humidified Culture and Live Birth After ICSI
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1837}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2019-01-27', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': '30 weeks', 'description': 'Viable neonate after 30 weeks of gestation per initiated cycle'}], 'secondaryOutcomes': [{'measure': 'Cumulative live birth rate', 'timeFrame': 'One year', 'description': 'Viable neonate after 30 weeks of gestation after one fresh and/or one frozen-warmed transfer per initiated cycle'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '12 weeks of gestation', 'description': 'Continued pregnancy after 12 weeks of gestation per initiated cycle'}, {'measure': 'Cumulative ongoing pregnancy rate', 'timeFrame': '12 weeks of gestation', 'description': 'Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '7 weeks of gestation', 'description': 'Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle'}, {'measure': 'Cumulative clinical pregnancy rate', 'timeFrame': '7 weeks of gestation', 'description': 'Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization'}, {'measure': 'Implantation rate', 'timeFrame': '7 weeks of gestation', 'description': 'Number of sacs with a heartbeat per number of embryo transferred'}, {'measure': 'Cumulative implantation rate', 'timeFrame': '7 weeks of gestation', 'description': 'Number of sacs with a heartbeat per number of embryo transferred within one year of randomization'}, {'measure': 'Ongoing implantation rate', 'timeFrame': '12 weeks of gestation', 'description': 'Number of sacs with a heartbeat per number of embryo transferred'}, {'measure': 'Cumulative ongoing implantation rate', 'timeFrame': '12 weeks of gestation', 'description': 'Number of sacs with a heartbeat per number of embryo transferred within one year of randomization'}, {'measure': 'Preterm birth rate', 'timeFrame': '37 weeks', 'description': 'number of babies born before 37 weeks of gestation per total birth'}, {'measure': 'Very preterm birth', 'timeFrame': '32 weeks', 'description': 'number of babies born before 32 weeks of gestation per total birth'}, {'measure': 'Low birth weight rate', 'timeFrame': '40 weeks of gestation', 'description': 'number of babies with \\< 2500 gm per total birth'}, {'measure': 'Fertilization rate', 'timeFrame': '6 days of culture', 'description': 'fertilized oocytes with two pronuclei per Metaphase II injected'}, {'measure': 'Cleavage rate', 'timeFrame': '6 days of culture', 'description': 'Cleaved embryo per fertilized oocyte'}, {'measure': 'Rate of high-quality day-3 embryos', 'timeFrame': '6 days of culture', 'description': 'Embryos with seven or eight blastomeres of appropriate-size, and \\< 10% fragmentation by volume per fertilized oocyte'}, {'measure': 'Blastocyst formation rate', 'timeFrame': '6 days of culture', 'description': 'Formed blastocyst on day 5/6 from fertilized oocytes'}, {'measure': 'Rate of high-quality blastocyst', 'timeFrame': '6 days of culture', 'description': 'Blastocysts ≥ 3.1.1 grade per fertilized oocyte'}, {'measure': 'Rate of utilizable blastocyst', 'timeFrame': '6 days of culture', 'description': 'Transferred and cryopreserved blastocysts from fertilized oocytes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'Humidity for human embryo culture has been raised as essential with advantageous effect on clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether the deleterious effect of dry culture would have an extended effect reaches the live birth rate needs to be examined. This RCT is to examine the effect of dry and humidified culture on live birth rates after ICSI.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing a first or second ICSI attempts\n* Primary or secondary infertility with a BMI of \\< 31 kg/m2\n* Duration of infertility of ≥ 18 months and normal baseline ultrasonography\n* 18 to 40 years of age\n* Tubal factor, male factor, polycystic ovary, unexplained infertility or combined factors\n* Tubal factors\n\nExclusion Criteria:\n\n* Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia\n* Thin endometrium\n* Uterine anomaly and adhesion\n* Adenomyosis\n* Submucous myoma\n* Endometriosis\n* Severe medical condition'}, 'identificationModule': {'nctId': 'NCT03823235', 'briefTitle': 'Humidified Culture and Live Birth After ICSI', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ibn Sina Hospital'}, 'officialTitle': 'Humidified Incubator Effect on Live Birth Rate After ICSI', 'orgStudyIdInfo': {'id': 'IbnSina-Humidity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Culture of human embryo in non-humidified incubator', 'description': 'Embryo culture after in vitro fertilization in incubator with no humidity', 'interventionNames': ['Other: Human embryo culture']}, {'type': 'NO_INTERVENTION', 'label': 'Culture of human embryo in humidified incubator', 'description': 'Embryo culture after in vitro fertilization in incubator with humidity'}], 'interventions': [{'name': 'Human embryo culture', 'type': 'OTHER', 'description': 'humidifed or dry incubator', 'armGroupLabels': ['Culture of human embryo in non-humidified incubator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '123456', 'city': 'Qina', 'state': 'Qena Governorate', 'country': 'Egypt', 'facility': 'Qena Fertility Center', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}, {'city': 'Asyut', 'country': 'Egypt', 'facility': 'Banon Assiut', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'city': 'Sohag', 'country': 'Egypt', 'facility': 'IbnSina IVF Center', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ibn Sina Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Banoon IVF Center', 'class': 'OTHER'}, {'name': 'Quena IVF Center', 'class': 'UNKNOWN'}, {'name': 'Amshag IVF Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lab Director', 'investigatorFullName': 'Muhammad Fawzy', 'investigatorAffiliation': 'Ibn Sina Hospital'}}}}