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临床试验/NCT02788617
NCT02788617已完成不适用

A Prospective, Non-interventional, Multicenter, Clinical Study to Evaluate the Efficacy of the Diafert G-CSF ELISA as an Adjunct to Morphological Assessment in Predicting Embryos' Potential to Develop to the Blastocyst Stage

Forest Laboratories9 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
9
主要终点
Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria

研究概览

简要总结

This prospective study will evaluate the efficacy of Diafert as an adjunct to morphological assessment in predicting embryos' potential to develop to the blastocyst stage on Day 5.

研究设计

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

入排标准

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

入选标准

  • Provide written informed consent before initiation of any study procedures
  • Be a female outpatient, ≥ 18 years of age at the time of informed consent
  • Have at minimum 10 mature egg follicles as of the last transvaginal ultrasound following hormonal stimulation
  • Eligible to allow embryos to develop through day 5 before implantation or freezing

排除标准

  • Presence of ovarian endometriotic cyst
  • Presence or history of diagnosed severe endometriosis (i.e. stage IV the revised American Fertility Society classification for endometriosis).
  • Need for pre-implantation genetic diagnosis/screening of embryos
  • Use of time-lapse embryo imaging
  • Employee or immediate relative of an employee of Forest Research Institute, Inc., any of its affiliates or partners, or the study center

结局指标

主要结局

Number of Embryos that achieve the blastocyst stage of development at Day 5 as determined by morphological assessment using the SART criteria

时间窗: Day 5

The status of each embryo will be assessed by an independent panel of 5 embryologists through visual inspection using the Society for Assisted Reproductive Technology (SART) criteria to determine if each embryo has achieved the blastocyst stage of development or not.

次要结局

未报告次要终点

研究者

发起方
Forest Laboratories
申办方类型
Industry
责任方
Sponsor

研究点 (9)

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