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临床试验/NCT06850909
NCT06850909尚未招募不适用

Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: a Randomized Trial

Ganin Fertility Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
Blastocyst Development rate

研究概览

简要总结

Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: A Randomized Trial

详细描述

The configuration of culture dishes plays a crucial role in preimplantation embryo development by influencing key culture conditions such as media distribution, oxygen exchange, and embryo spacing, all of which directly impact embryonic growth, fertilization, blastocyst formation, and overall blastocyst quality. Traditional 2D culture dishes provide a flat surface for embryo development, whereas 3D culture dishes create a microenvironment that better mimics in vivo conditions by optimizing nutrient availability and reducing stress from environmental fluctuations. In this study, we compare the effects of two different 3D culture dishes-Dish 1 (Microdrop GPS Dish) and Dish 2 (16-Well BIRR Dish)-on preimplantation genetic outcomes. Using a sibling oocyte split design, oocytes were randomly divided after intracytoplasmic sperm injection (ICSI) and cultured in either dish, ensuring that each patient serves as their own internal control. Embryo development was closely monitored from fertilization to blastocyst formation, to determine whether dish design has a significant impact on preimplantation embryo development.

研究设计

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

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Female patients aged 35 years or younger
  • •A minimum of 15 mature oocytes available for ICSI
  • •Classified as a good prognosis patient

排除标准

  • •Cases with severe DNA fragmentation
  • •Patients undergoing FNA or TESE procedures
  • •Severe male factor infertility
  • •History of low or failed fertilization in previous cycles
  • •Any contraindications to gonadotropin stimulation
  • •Presence of leukocytospermia

研究组 & 干预措施

Dish no.1

Active Comparator

Sibling oocytes were randomly allocated for culture in Dish 1 (Microdrop GPS Dish) from the ICSI procedure until the blastocyst stage.

干预措施: Microdrop GPS dish (Device)

Dish no.2

Active Comparator

Sibling oocytes were randomly allocated for culture in Dish 1 (16 well BIRR Dish) from the ICSI procedure until the blastocyst stage.

干预措施: 16 well BIRR dish (Device)

结局指标

主要结局

Blastocyst Development rate

时间窗: 5 - 6 days

Defined as the proportion of blastocysts formed on day 5 or 6

次要结局

  • Fertilization rate(1 day)
  • Cleavage rate(3 days)
  • Blastocyst Quality rate(5 - 6 days)
  • High Quality Day 3 rate(3 days)

研究者

发起方
Ganin Fertility Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eman Hasanen

ESHRE certified Clinical Embryologist

Ganin Fertility Center

研究点 (1)

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