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临床试验/NCT06220227
NCT06220227已完成不适用

The Embryologist's Impact on Blastocyst Vitrification and Thawing: a Monocentric Retrospective Study With an External Validation Study.

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 6,800 人开始时间: 2019年1月1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
6,800
试验地点
1
主要终点
clinical pregancy rate

研究概览

简要总结

The goal of this monocentric retrospective observational study is to analyse, for the first time in literature, the role of the embryologist who freezes and thaws the embryos.

The primary objective of the study is to understand whether the embryologist who freezes and thaws the embryo influences the CPR (clinical pregnancy rate).

Secondary objectives, in case of statistically significant influence, are:

  • Evaluate who influences more the CPR, between the embryologist who freezes the embryos and the embryologist who thaws the embryos.
  • Evaluate if the embryologist who freezes and thaws the embryo impacts more than the embryologist or the physician who performs the ET.
  • Evaluate whether the embryologists improve their performances, as their experience increases.
  • Evaluate, through an external validation test, whether the model used can also be applied at other PMA centres

The study will consider all the freezing (vitrifications) and thawing procedures, performed at Humanitas Fertility Center between January 2019 and June 2023.

The study will include the transfers of single blastocysts, cryopreserved at Humanitas Fertility Center. On the other hand, the blastocysts transferred from other centres and the donor blastocysts will be excluded from the study, as well as multiple blastocysts transfers and the LP cycles.

The embryologist's experience will be assessed in terms of number of previous cryopreservation (vitrification) and thawing procedures. We will include in the study all the embryologists who performed at least 50 freezing and thawing.

For the evaluation of the study objectives, data will be gathered using a specific internal web-based database.

The final model will be created by analysing the Humanitas Fertility Center dataset and validated using datasets extrapolated from similar population from the San Raffaele Hospital infertility centre

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The study database will include all the patients who performed a single cryopreserved blastocyst transfer, between January 2019 and June 2023, including also PGTA and repeated ART cycles.
  • The embryologist's experience will be assessed in terms of number of previous cryopreservation (vitrification) and thawing procedures. We will include in the study all the embryologists who performed at least 50 freezing and thawing.

排除标准

  • The blastocysts transferred from other centres and the donor blastocysts will be excluded from the study, as well as multiple blastocysts transfers and the LP cycles, to reduce the risk of selection bias or physician-embryologist couple bias.
  • The embryologists who performed less than 50 freezing and thawing will be excluded from the study.
  • Similarly, the first 50 procedures performed by each embryologist will not be counted in the data set.

结局指标

主要结局

clinical pregancy rate

时间窗: January 2019-June 2023

visualisation of the gestation sac in the uterus by ultrasound over the number of ET cycles performed

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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