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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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注册号：

Registration number：

 ChiCTR1900022391 

最近更新日期：

Date of Last Refreshed on：

 2019-04-09 22:12:46 

注册时间：

Date of Registration：

 2019-04-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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.

Scientific title：

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.

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Alqawasmeh, Odai Ali Mohammad 

研究负责人：

Professor LI Tin Chiu 

Applicant：

Alqawasmeh, Odai Ali Mohammad 

Study leader：

Professor LI Tin Chiu 

申请注册联系人电话：

Applicant telephone：

 +852 5178 2619

研究负责人电话：

Study leader's
telephone：

+852 3505 2800

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 Alqawasmeh.Odai@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 tinchiu.li@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中國香港特別行政區新界沙田威爾士親王醫院特F座

研究负责人通讯地址：

中國香港特別行政區新界沙田威爾士親王醫院特E座

Applicant address：

9F, Special Block F, Prince of Wales Hospital, Shatin, Hong Kong

Study leader's address：

1F, Special Block E, Prince of Wales Hospital, Shatin, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學婦產科學系

Applicant's institution：

Department of Obstetrics & Gynaecology/ CUHK

研究负责人所在单位：

香港中文大學婦產科學系

Affiliation of the Leader：

Department of Obstetrics & Gynaecology/ CUHK

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2018.423-T

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

Jemmy NG

Contact Name of the ethic committee：

Jemmy NG

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8/F

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

香港中文大學婦產科學系

Primary sponsor：

Department of Obstetrics & Gynaecology/ CUHK

研究实施负责（组长）单位地址：

中國香港特別行政區新界沙田威爾士親王醫院特E座

Primary sponsor's address：

1F, Special Block E, Prince of Wales Hospital, Shatin, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong Special Administrative Region

City：

Shatin

单位(医院)：

香港中文大學婦產科學系

具体地址：

中國香港特別行政區新界沙田威爾士親王醫院特E座

Institution
hospital：

Department of Obstetrics & Gynaecology/ CUHK

Address：

1F, Special Block E, Prince of Wales Hospital, Shatin, Hong Kong

经费或物资来源：

香港中文大學婦產科學系

Source(s) of funding：

Department of Obstetrics & Gynaecology/ CUHK

研究疾病：

不育症  

Target disease：

infertility

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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?  

Objectives of Study：

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?

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

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).

Exclusion criteria：

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).

研究实施时间：

Study execute time：

从 From 2018-02-01 00:00:00至 To 2021-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-04-15 00:00:00 至 To 2021-01-15 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 525

Group：

Group 1

Sample size：

干预措施：

incubation and assessment of embryos using TLI systems

干预措施代码：

Intervention：

incubation and assessment of embryos using TLI systems

Intervention code：

组别：

Group 2

样本量：

 525

Group：

Group 2

Sample size：

干预措施：

incubation of embryos in undisturbed culture and standard embryo assessment

干预措施代码：

Intervention：

incubation of embryos in undisturbed culture and standard embryo assessment

Intervention code：

组别：

试验组

样本量：

 525

Group：

Control group

Sample size：

干预措施：

Standard care

干预措施代码：

Intervention：

Standard care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

Shatin

单位(医院)：

 威爾士親王醫院 

单位级别：

 三甲医院 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Tertiary A Hospital

国家：

 聯合王國

省(直辖市)：

 倫敦 

市(区县)：

  

Country：

United Kingdom

Province：

London

City：

单位(医院)：

 Homerton University Hospital 

单位级别：

 Homerton University Hospital 

Institution
hospital：

Homerton University Hospital

Level of the institution：

Homerton University Hospital

国家：

 聯合王國

省(直辖市)：

 Bath 

市(区县)：

  

Country：

United kingdom

Province：

Bath

City：

单位(医院)：

 Bath Fertility Centre 

单位级别：

 Bath Fertility Centre 

Institution
hospital：

Bath Fertility Centre

Level of the institution：

Bath Fertility Centre

国家：

 聯合王國

省(直辖市)：

 倫敦 

市(区县)：

  

Country：

United kingdom

Province：

London

City：

单位(医院)：

 Hammersmith Hospital 

单位级别：

 Hammersmith Hospital 

Institution
hospital：

Hammersmith Hospital

Level of the institution：

Hammersmith Hospital

国家：

 聯合王國

省(直辖市)：

 倫敦 

市(区县)：

  

Country：

United Kingdom

Province：

London

City：

单位(医院)：

 St Bartholomew’s Hospital 

单位级别：

 St Bartholomew’s Hospital 

Institution
hospital：

St Bartholomew’s Hospital

Level of the institution：

St Bartholomew’s Hospital

测量指标：

Outcomes：

指标中文名：

Live birth

指标类型：

主要指标

Outcome：

Live birth

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Live birth

Measure method：

指标中文名：

Clinical efficacy

指标类型：

次要指标

Outcome：

Clinical efficacy

Type：

Secondary indicator

测量时间点：

测量方法：

Implantation rates, elective single embryo transfer

Measure time point of outcome：

Measure method：

Implantation rates, elective single embryo transfer

指标中文名：

Clinical safety

指标类型：

次要指标

Outcome：

Clinical safety

Type：

Secondary indicator

测量时间点：

测量方法：

multiple births, miscarriages, stillbirths and major congenital abnormalities at birth

Measure time point of outcome：

Measure method：

multiple births, miscarriages, stillbirths and major congenital abnormalities at birth

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Embryos

组织：

Sample Name：

Embryos

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

Randomised patients for fresh embryo transfer will have their embryo/s transferred into the uterus on either Day 3 or Day 5 after the egg collection (or Day 6 if applicable). The participating centre can decide the day of embryo transfer and the number of embryos to be transferred according to their

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 42 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

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

Randomization Procedure (please state who generates the random number sequence and by what method)：

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 a

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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.

Blinding：

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.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

will be through publications and presentations at major national and international conferences relevant to the specialty.

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

will be through publications and presentations at major national and international conferences relevant to the specialty.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

All data management will be undertaken by Queen Mary University of London. Standard operating procedures will be in place for the collection and handling of data received at the Unit. All study data will be entered into a secure, bespoke electronic trial database with restricted access. Data collected on the data collection forms and entered onto the electronic database will only identify the participants by a unique trial number

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

All data management will be undertaken by Queen Mary University of London. Standard operating procedures will be in place for the collection and handling of data received at the Unit. All study data will be entered into a secure, bespoke electronic trial database with restricted access. Data collected on the data collection forms and entered onto the electronic database will only identify the participants by a unique trial number

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-04-09 22:12:46
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