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临床试验/NCT07270250
NCT07270250招募中不适用

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

ART Fertility Clinics LLC1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Day 5 blastulation versus total blastulation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • PGT-A cycles with more than at least 4 mature oocytes
  • 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
  • fresh and frozen ejaculated sperm

排除标准

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

研究组 & 干预措施

Dry Chamber of Geri

Other

干预措施: K- system incubator (Device)

Humidified Chamber of Geri

Other

干预措施: K- system incubator (Device)

结局指标

主要结局

Day 5 blastulation versus total blastulation

时间窗: Day 5 post-insemination

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

Blastocyst quality at time of biopsy based on modified Gardner's criteria.

时间窗: Day 5 post-insemination

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.

Day 5 blastulation versus total blastulation

时间窗: Day 5 post-insemination

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

Blastocyst quality at time of biopsy based on modified Gardner's criteria.

时间窗: Day 5 post-insemination

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.

次要结局

  • Rate of day 5 biopsy(Day 5 post-insemination)
  • Total blastulation rates per MII and 2PN.(Day 5 post-insemination)
  • Ploidy rate/biopsy and types of aneuploidies (segmental and mosaic)(Day 5 post-insemination)
  • Blastocyst utilization rate(30 days)
  • Total blastulation rates per MII and 2PN.(Day 5 post-insemination)
  • Ploidy rate/biopsy and types of aneuploidies (segmental and mosaic)(Day 5 post-insemination)
  • Blastocyst utilization rate(30 days)
  • Rate of day 5 biopsy(Day 5 post-insemination)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

leroy vas

Embryologist

ART Fertility Clinics LLC

研究点 (1)

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