Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00416

2 Trial Registration Date

2014-06-05

i Registration Status

Prospective

3 Secondary IDs

CREC Ref. no.:2014.259

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

Please specify

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

i Name

Carol Chan

ii Address

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

iii Phone

26321764

iv Email

carolchan@cuhk.edu.hk

v Affiliation

CUHK

vi Country

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

i Name

Dr. Grace Wing Shan KONG

ii Address

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

iii Phone

26322996

iv Email

gracekong@cuhk.edu.hk

v Affiliation

CUHK

vi Country

9 Official Scientific Title of the Study

A multi-centre study of psychiatric morbidity among infertile Chinese women in Hong Kong

10 Public Title

A multi-centre study of psychiatric morbidity among infertile Chinese women in Hong Kong

i Public Title in Chinese 研究名稱

心理壓力與不育症之關係研究

11 Short Title (Optional)

Psychiatric morbidity study on infertile Hong Kong women

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?

2014-05-21

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

infertility

15 Intervention

i Types of intervention

Other

Please specify

Questionnaire

ii Description/ name of Intervention/article

Questionnaire

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30minutes to complete the questionnaire

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients attending the Infertility clinic at Prince of Wales Hospital and Pamela Youde Nethersole Eastern Hospital

ii Exclusion Criteria

- patients who are non-Chinese;
- patients who are unwilling to participate;
- patients who have known psychiatric disease(s); patients who have known chronic disease(s)

iii Age Minimum

18

iv Age Maximum

40

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-07-06

21 Target Sample Size

300

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

GHQ-12,BDI,STAI,Questionnaire on socio-cultural factors,Questionnaire on utilisation nad perceived need of professional psychological support

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-07

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2014-06-05