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临床试验/NCT05189405
NCT05189405Unknown不适用

A 3 Year Retrospective Analysis of Fertility Clinic's of In Vitro Fertilization (IVF) in Comparison With INVOcell Intravaginal Culture (INVOcell IVC) Device

INVO Bioscience, Inc.4 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2021年10月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
450
试验地点
4
主要终点
Embryo development

研究概览

简要总结

Retrospective chart review of data on the use of traditional IVF and INVOcell IVC collected from clinics using both technologies. The retrospective data will be utilized for a comparison of the two methods.

详细描述

The following aspects of data will be collected to support the analysis of the two methods

  • Procedure details for including oil overlay and incubation time frame
  • Characteristics of embryo quality and phase of development and transfer rates
  • Clinical pregnancy rate
  • Live birth rate Secondary: Data regarding safety
  • Adverse events noted by the women that received IVF and INVOcell IVC
  • Adverse events noted for the offspring

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Subjects that have received infertility treatment with either INVOcell IVC or standard IVF during the same timeframe. All subjects treated with the standard of care IVF method during the same timeframe that the center used INVOcell IVC were included in the retrospective data collection.

排除标准

  • Not applicable

结局指标

主要结局

Embryo development

时间窗: 5 days

Characteristics of embryo quality and phase of development and transfer rates

Clinical pregnancy rate

时间窗: 5 days

Clinical pregnancy rate

Live birth rate

时间窗: 5 days

Live birth rate

次要结局

  • Offspring adverse events(5 days)
  • Maternal Adverse Events(5 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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