Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT07270250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte Study
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': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Day 5 blastulation versus total blastulation', 'timeFrame': 'Day 5 post-insemination', 'description': 'Day 5 blastulation versus total blastulation refers to comparing the proportion of embryos that reach the blastocyst stage specifically by Day 5 against the overall number of embryos that eventually form blastocysts'}, {'measure': "Blastocyst quality at time of biopsy based on modified Gardner's criteria.", 'timeFrame': 'Day 5 post-insemination', 'description': "Blastocyst quality at the time of biopsy will be assessed using the modified Gardner's grading system, which evaluates three key components of the blastocyst: the degree of expansion, the quality of the inner cell mass (ICM), and the quality of the trophectoderm (TE). This standardized scoring allows objective comparison of embryo morphology and developmental competence at the moment of trophectoderm biopsy."}], 'secondaryOutcomes': [{'measure': 'Total blastulation rates per MII and 2PN.', 'timeFrame': 'Day 5 post-insemination', 'description': 'Total blastulation rates per MII and per 2PN refer to the proportion of inseminated mature oocytes (MII) and normally fertilized zygotes (2PN) that successfully develop into blastocysts, regardless of whether they reach this stage on Day 5 or Day 6. This measurement reflects the overall efficiency of embryo development from both the point of maturation and normal fertilization.'}, {'measure': 'Ploidy rate/biopsy and types of aneuploidies (segmental and mosaic)', 'timeFrame': 'Day 5 post-insemination', 'description': 'Ploidy rate per biopsy refers to the proportion of biopsied blastocysts that return a euploid, aneuploid, mosaic or segmental result after PGT-A testing. This includes reporting the distribution of chromosomal abnormalities identified, distinguishing between full aneuploidies (whole chromosome gain or loss), segmental aneuploidies (partial chromosome changes) and mosaic patterns (mixed normal and abnormal cell lines). This outcome reflects the chromosomal competence of embryos generated under each culture condition.'}, {'measure': 'Blastocyst utilization rate', 'timeFrame': '30 days', 'description': 'Blastocyst utilization rate refers to the proportion of blastocysts that are suitable for clinical use-meaning those that are either transferred, frozen for future use, or biopsied for PGT-A.'}, {'measure': 'Rate of day 5 biopsy', 'timeFrame': 'Day 5 post-insemination', 'description': 'Rate of Day 5 biopsy refers to the proportion of blastocysts that reach the biopsy stage specifically on Day 5, relative to the total number of blastocysts biopsied.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Incubator Stay', 'Total Blastulation', 'Blastocyst Quality', 'Biopsy Rate', 'Fertilization Rate', 'Ploidy Rate', 'ICSI']}, 'referencesModule': {'references': [{'pmid': '37133689', 'type': 'RESULT', 'citation': "Bartolacci A, Borini A, Cimadomo D, Fabozzi G, Maggiulli R, Lagalla C, Pignataro D, dell'Aquila M, Parodi F, Patria G, Zaca C, Ubaldi FM, Rienzi L, Coticchio G. Humidified atmosphere in a time-lapse embryo culture system does not improve ongoing pregnancy rate: a retrospective propensity score model study derived from 496 first ICSI cycles. J Assist Reprod Genet. 2023 Jun;40(6):1429-1435. doi: 10.1007/s10815-023-02818-8. Epub 2023 May 3."}, {'pmid': '33751461', 'type': 'RESULT', 'citation': 'Ueno S, Ito M, Shimazaki K, Okimura T, Uchiyama K, Yabuuchi A, Kato K. Comparison of Embryo and Clinical Outcomes in Different Types of Incubator Between Two Different Embryo Culture Systems. Reprod Sci. 2021 Aug;28(8):2301-2309. doi: 10.1007/s43032-021-00504-7. Epub 2021 Mar 9.'}, {'pmid': '28651960', 'type': 'RESULT', 'citation': 'Fawzy M, AbdelRahman MY, Zidan MH, Abdel Hafez FF, Abdelghafar H, Al-Inany H, Bedaiwy MA. Humid versus dry incubator: a prospective, randomized, controlled trial. Fertil Steril. 2017 Aug;108(2):277-283. doi: 10.1016/j.fertnstert.2017.05.036. Epub 2017 Jun 23.'}, {'pmid': '33227188', 'type': 'RESULT', 'citation': 'Chi HJ, Park JS, Yoo CS, Kwak SJ, Son HJ, Kim SG, Sim CH, Lee KH, Koo DB. Effect of evaporation-induced osmotic changes in culture media in a dry-type incubator on clinical outcomes in in vitro fertilization-embryo transfer cycles. Clin Exp Reprod Med. 2020 Dec;47(4):284-292. doi: 10.5653/cerm.2020.03552. Epub 2020 Nov 23.'}, {'pmid': '35811802', 'type': 'RESULT', 'citation': 'Cheredath A, Uppangala S, Asampille G, Lakshmi R V, Joseph D, Raval K, Gowda G A N, Kalthur G, Adiga SK. Duration of dry and humidified incubation of single-step embryo culture medium and oxygen tension during sham culture do not alter medium composition. F1000Res. 2022 Feb 28;11:242. doi: 10.12688/f1000research.109895.4. eCollection 2022.'}, {'pmid': '32083189', 'type': 'RESULT', 'citation': "Castillo CM, Harper J, Roberts SA, O'Neill HC, Johnstone ED, Brison DR. The impact of selected embryo culture conditions on ART treatment cycle outcomes: a UK national study. Hum Reprod Open. 2020 Feb 10;2020(1):hoz031. doi: 10.1093/hropen/hoz031. eCollection 2020."}]}, 'descriptionModule': {'briefSummary': 'IVF incubators are essential for maintaining the micro-environment required for embryo development. Incubator technology has progressed from early humidified box systems to benchtop and now time-lapse platforms, driving the development of dry incubator chambers. Both humidified and dry systems have specific pros and cons. Evidence to date suggests that humidified chambers may support better blastocyst development in certain "no-refresh" continuous culture conditions, but current data are limited and study designs remain weak. This study aims to compare sibling oocytes cultured in dry versus humidified chambers within a GERI time-lapse incubator under continuous culture conditions, assessing effects on viability and developmental outcomes. Findings may inform optimal incubation strategies to improve IVF success rates while supporting uninterrupted workflows and potentially improving cost-benefit efficiency in the IVF laboratory.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PGT-A cycles with more than at least 4 mature oocytes\n* ICSI\n* maternal age 18- 43 years old\n* PGT-A intended cycles with trophectoderm biopsies on day 5 /6/7\n* patients with more than 8 oocytes expected for ICSI\n* BMI \\<35\n* fresh and frozen ejaculated sperm\n\nExclusion Criteria:\n\n* PGT-M /PGT-SR cycles\n* fresh and frozen testicular sperm\n* IVF insemination\n* previous history of fertilization failure'}, 'identificationModule': {'nctId': 'NCT07270250', 'briefTitle': 'Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte Study', 'organization': {'class': 'OTHER', 'fullName': 'ART Fertility Clinics LLC'}, 'officialTitle': 'Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte Study', 'orgStudyIdInfo': {'id': '2504-ABU-013-LV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dry Chamber of Geri', 'interventionNames': ['Device: K- system incubator']}, {'type': 'OTHER', 'label': 'Humidified Chamber of Geri', 'interventionNames': ['Device: K- system incubator']}], 'interventions': [{'name': 'K- system incubator', 'type': 'DEVICE', 'description': "Following oocyte retrieval, collected oocytes will be incubated in Global Total for Fertilization within a K-Systems incubator until the time of denudation and intracytoplasmic sperm injection (ICSI). All mature (MII) oocytes will undergo ICSI at 39-41 hours post-trigger. After insemination, sibling oocytes will be divided as equally as possible and randomly allocated into two separate Geri incubator chambers: Group 1 will be cultured in the dry chamber, and Group 2 will be cultured in the humidified chamber. A predefined randomization list will determine allocation, including cases with an uneven number of oocytes, where the additional oocyte will be assigned according to the list. Both groups will use Global TotalR (GT, CooperSurgical) single-step medium. Embryo culture will be carried out in continuous culture conditions until the blastocyst stage, following the manufacturer's GT protocol, with no Day 3 media refreshment. To minimize procedural variability, one operator will ideally", 'armGroupLabels': ['Dry Chamber of Geri', 'Humidified Chamber of Geri']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60202', 'city': 'Abu Dhabi', 'state': 'Abu Dhabi Emirate', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Jonalyn Edades, Research Coordinator', 'role': 'CONTACT', 'email': 'jonalyn.edades@artfertilityclinics.com', 'phone': '+97126528000'}, {'name': 'Barbara Lawrenz, Research Director', 'role': 'CONTACT', 'email': 'barbara.lawrenz@artfertilityclinics.com'}], 'facility': 'ART Fertility Clinics LLC', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'JONALYN EDADES, EMBA Healthcare Management', 'role': 'CONTACT', 'email': 'jonalyn.edades@artfertilityclinics.com', 'phone': '+97126528000'}], 'overallOfficials': [{'name': 'BARBARA LAWRENZ, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ART Fertility Clinics LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ART Fertility Clinics LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Embryologist', 'investigatorFullName': 'leroy vas', 'investigatorAffiliation': 'ART Fertility Clinics LLC'}}}}