Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00442

2 Trial Registration Date

2015-01-20

i Registration Status

Prospective

3 Secondary IDs

CRE-2014.573

4 Source(s) of Funding

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

5 Primary Sponsor

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

6 Secondary Sponsor

Nil

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

TSE Lai Yiu

ii Address

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

iii Phone

35051764

iv Email

eristse@cuhk.edu.hk

v Affiliation

Department of Obstetrics &Gynaecology, Prince of Wales Hospital

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Grace Kong

ii Address

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

iii Phone

3505 2996

iv Email

gracekong@cuhk.edu.hk

v Affiliation

Department of Obstetrics &Gynaecology, Prince of Wales Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

Additional information from array comparative genomic hybridization technology over conventional karyotyping on diagnosing genetic cause of women with recurrent miscarriage

10 Public Title

Additional information from array comparative genomic hybridization technology over conventional karyotyping on diagnosing genetic cause of women with recurrent miscarriage

i Public Title in Chinese 研究名稱

傳統染色體分析與微陣列芯片(array-CGH)比較基因組分析對基因問題導致的慣性流產的研究

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-12-04

iii Full Name of IRB/IEC

New Territories West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2014.573

14 Medical Condition Being Studied

women with recurrent miscarriage

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

5ml of blood and product of miscarriage will be collected for cytogenetic study including conventional karyotyping and aCGH analysis.

iii Dosage form of the intervention

nil

iv Dosage of the intervention

nil

v Duration of the intervention

on the day of miscarriage

vi Frequency of the intervention

once

16 Comparative Treatments

i Description/ name of comparative treatments

nil

ii Dosage form of the comparative treatments

nil

iii Dosage of the comparative treatments

nil

iv Duration of the comparative treatments

nil

v Frequency of the comparative treatments

nil

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

women with a prior history of recurrent miscarriage who have been admitted with a diagnosis of miscarriage will be invited to participate in the study

ii Exclusion Criteria

women without history of unexplained recurrent miscarriage

iii Age Minimum

18

iv Age Maximum

45

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-02-01

21 Target Sample Size

100

22 Recruitment Status

Recruiting

23 Primary Outcome

This study can help to decide the best first line genetic test for recurrent miscarriage

24 Secondary Outcome

to determine the recurrence risk, aid counseling for future pregnancies and aids prevention worldwide.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-11-09

27 Primary Registry and Trial Identifying Number

ChiCTR-OOC-15005866

28 Date of Registration in Primary Registry

2015-01-23

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Trial History Detail on 2017-06-05