跳至主要内容
临床试验/NCT05671601
NCT05671601尚未招募不适用

Application of Deep Learning Automation Based on Time-lapse Imaging to Jointly Assess Embryo Development to Improve Pregnancy Outcome of Single Blastocyst Transfer

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School0 个研究点目标入组 100 人开始时间: 2022年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
implantation rate

研究概览

简要总结

Aim of this research is to apply the deep learning automation based on Time-lapse imaging to jointly assess embryo development,so that it can ensure the consistency of embryo evaluation and improve the accuracy of evaluation.

详细描述

This study is an observational prospective study after a retrospective analysis. It is a single-center study without randomization or blindness. In the early stage, 1000 patients are collected from three periods of embryo culture through Time-lapse to establish an automated joint evaluation system for the whole process of embryo development. At the later stage, the patients are divided into two groups: Time-Lapse imaging (TLI) +Artificial Intelligence(AI) assessment group and morphological assessment group. 100 patients with Day 5 single blastocyst transplantation are carried out to follow up the pregnancy outcome.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • (1) Age < 40 years old; (2) Routine IVF cycles; (3) Period number ≤ 2; (4) The number of ova collected is 5-15; (5) BMI: 18-25 kg/m 2, follicle stimulating hormone(FSH) ≤ 12 IU/L on the third day; (6) Patients with more than 3 high-quality embryos on Day3 and performed single blastocyst transplantation on day
  • (7) Patient without endometrial factors.

排除标准

  • (1) Preimplantation Genetic Testing(PGT) is needed due to male infertility, ovulation cycle and chromosome abnormalities; (2) there are systemic diseases of clinical significance; (3) Pictures of blastocysts are not formed or available; (4) Incomplete or unclear image collection in prokaryotic, mitotic and blastocyst phases affected AI evaluation.

结局指标

主要结局

implantation rate

时间窗: 2022-2023

the probability of successful implantation of the embryo into the uterus

次要结局

未报告次要终点

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Sponsor

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