【ChiCTR1900022391】A pragmatic, multi-centre, three-arm randomised controlled trial to assess the clinical effectiveness and safety of time lapse imaging in in-vitro fertilisation treatment

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基本信息

登记号

ChiCTR1900022391

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2019-04-09

临床申请受理号

靶点

适应症

不育症

试验通俗题目

A pragmatic, multi-centre, three-arm randomised controlled trial to assess the clinical effectiveness and safety of time lapse imaging in in-vitro fertilisation treatment

试验专业题目

A pragmatic, multi-centre, three-arm randomised controlled trial to assess the clinical effectiveness and safety of time lapse imaging in in-vitro fertilisation treatment.

申办单位信息

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临床试验信息

试验目的

Primary objectives: The primary objective of the trial is to determine if the use of TLI or undisturbed culture in IVF/ICSI treatment results in a higher live birth rate when compared to current standard methods of embryo incubation and assessment. Secondary objectives: The trial aims to answer the following questions and the secondary objectives of the trial are: 1. To obtain measures of clinical effectiveness of TLI/undisturbed culture: (1) Are clinical pregnancy rates and implantation rates increased with the use of TLI/undisturbed culture in IVF/ICSI treatment? Does the use of TLI/undisturbed culture increase the number of women having an elective single embryo transfer? 2. To obtain measures of clinical safety of TLI/undisturbed culture: (1) Does the use of TLI/undisturbed culture decrease the incidence of multiple births following IVF/ICSI treatment? (2) Does the use of TLI/undisturbed culture decrease the incidence of miscarriages following IVF/ICSI treatment? (3) Are stillbirths and major congenital abnormalities at birth decreased with the use of TLI/undisturbed culture in IVF/ICSI treatment?

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

Randomisation will be performed on the day of fertilisation check. Participants satisfying all the eligibility criteria for the trial will be randomised into one of the three treatment arms in a 1:1:1 ratio. 1) time-lapse imaging 2) undisturbed culture 3) standard treatment Randomisation will be done by a trained

盲法

It will not be possible to blind embryologists to the intervention. All other local and central trial staff, including clinicians performing the embryo transfer and data analysts, will be blinded. Participants will be blinded to the allocated intervention until the end of their participation in the trial. This will either be a negative pregnancy test which is approximately 2 weeks after embryo transfer or the end of their pregnancy.

试验项目经费来源

香港中文大學婦產科學系

试验范围

目标入组人数

525

实际入组人数

第一例入组时间

2018-02-01

试验终止时间

2021-07-31

是否属于一致性

入选标准

The inclusion criteria are broad in keeping with the latest NICE guidelines (2013) for NHS funded IVF/ICSI treatment. Participants undergoing IVF/ICSI treatment and 1) the woman is between 18 and 42 years of age at the time of consent; 2) the male partner is at least 18 years of age at the time of consent; 3) receiving the first, second or third IVF/ICSI treatment cycle; 4) both partners give written informed consent; 5) those having at least 3 2PN embryos (showing 2 pro-nucleii which is a sign of normal fertilisation) on day of fertilization check.；

排除标准

1) Participants who have been randomised previously to this trial; 2) Participants concomitantly participating in other trials; 3) IVF/ICSI treatment using donor gametes; 4) Planned pre-implantation genetic diagnostics or screening (PGS/PGD).；

研究者信息

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试验机构

香港中文大學婦產科學系

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