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Идёт набор NCT07270250

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

Без фазы С лечением Incubator Stay Total Blastulation Blastocyst Quality Biopsy Rate

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: K- system incubator.
Кому может быть актуально
Состояния в реестре: Incubator Stay, Total Blastulation, Blastocyst Quality, Biopsy Rate. Базовые параметры: 18 лет — 43 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
ОАЭ
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Вмешательства

  • Устройство 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Другое

Центры проведения

ОАЭ · 1 центр
  • ART Fertility Clinics LLC — Abu Dhabi

Публикации

  • 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

Идентификаторы

NCT: NCT07270250 · 2504-ABU-013-LV

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗