Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte Study
NCT ID: NCT07270250
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Dry Chamber of Geri
K- system incubator
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
Humidified Chamber of Geri
K- system incubator
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
Interventions
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K- system incubator
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
Eligibility Criteria
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Inclusion Criteria
* ICSI
* maternal age 18- 43 years old
* PGT-A intended cycles with trophectoderm biopsies on day 5 /6/7
* patients with more than 8 oocytes expected for ICSI
* BMI \<35
* fresh and frozen ejaculated sperm
Exclusion Criteria
* fresh and frozen testicular sperm
* IVF insemination
* previous history of fertilization failure
18 Years
43 Years
FEMALE
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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leroy vas
Embryologist
Principal Investigators
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BARBARA LAWRENZ, PhD
Role: STUDY_DIRECTOR
ART Fertility Clinics LLC
Locations
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ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2504-ABU-013-LV
Identifier Type: -
Identifier Source: org_study_id
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