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Recruiting NCT07270250

Impact of Dry vs Humidified Culture Conditions on Blastocyst Development and Aneuploidy: A Time-lapse Sibling Oocyte Study

No phase Interventional Incubator Stay Total Blastulation Blastocyst Quality Biopsy Rate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: K- system incubator.
Who it may be relevant to
Registry conditions: Incubator Stay, Total Blastulation, Blastocyst Quality, Biopsy Rate. Basic parameters: 18 years — 43 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Arab Emirates
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device 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 humid

Primary outcome measures

  • Day 5 blastulation versus total blastulation [Time frame: Day 5 post-insemination]
  • Blastocyst quality at time of biopsy based on modified Gardner's criteria. [Time frame: Day 5 post-insemination]
Secondary outcome measures (4)
  • Total blastulation rates per MII and 2PN. [Time frame: Day 5 post-insemination]
  • Ploidy rate/biopsy and types of aneuploidies (segmental and mosaic) [Time frame: Day 5 post-insemination]
  • Blastocyst utilization rate [Time frame: 30 days]
  • Rate of day 5 biopsy [Time frame: Day 5 post-insemination]

Eligibility criteria

Inclusion criteria

  • PGT-A cycles with more than at least 4 mature oocytes
  • 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

  • PGT-M /PGT-SR cycles
  • fresh and frozen testicular sperm
  • IVF insemination
  • previous history of fertilization failure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Other

Study locations

United Arab Emirates · 1 center
  • ART Fertility Clinics LLC — Abu Dhabi

Publications

  • 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. PMID 37133689
  • 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 33751461
  • 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 28651960
  • 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 33227188
  • 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 35811802
  • 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. PMID 32083189

Identifiers

NCT: NCT07270250 · 2504-ABU-013-LV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗