Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00652

2 Trial Registration Date

2019-01-04

i Registration Status

Prospective

3 Secondary IDs

2018.514

4 Source(s) of Funding

NA

5 Primary Sponsor

NA

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Elaine NG

ii Address

Room 3EF, 3/F, Special Block EF,
Prince of Wales Hospital,
Sha Tin, New Territories, H.K.

iii Phone

35052745

iv Email

elaineng@link.cuhk.edu.hk

v Affiliation

Department of O&G, CUHK

vi Country

Hong Kong

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

i Name

CHUNG Pui Wah, Jacqueline

ii Address

1E, 1/F, Special Block EF,
Prince of Wales Hospital,
Sha Tin, New Territories, H.K.

iii Phone

35052585

iv Email

jacquelinechung@cuhk.edu.hk

v Affiliation

Department of O&G, Prince of Wales Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

Validation of a Fertility Status Awareness Tool (FertiSTAT) to Access the Fertility Problem among Hong Kong Chinese

10 Public Title

確認中文版生育狀況檢測問卷

i Public Title in Chinese 研究名稱

確認中文版生育狀況檢測問卷

11 Short Title (Optional)

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?

2018-12-22

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.514

14 Medical Condition Being Studied

Pregnant and infertile women

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Questionnaire validation

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

NA

vi Frequency of the intervention

NA

16 Comparative Treatments

i Description/ name of comparative treatments

NA

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1) Hong Kong Chinese with Hong Kong Identity Card; (2) age ≥ 18 years old; (3) able to speak Cantonese; (4) currently pregnant or meeting the clinical criteria for referral for infertility diagnosis; and (5) able to give informed verbal consent.

ii Exclusion Criteria

Exclusion criteria include those with age above 45 years old, unable to speak Cantonese, neither pregnant nor meeting the clinical criteria for referral for infertility diagnosis, and unable to understand and give informed verbal consent for the study.

iii Age Minimum

18

iv Age Maximum

45

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2019-01-11

21 Target Sample Size

466

22 Recruitment Status

Complete

23 Primary Outcome

i The Name of the outcome

Major outcome measure is the validity of the questionnaire among Hong Kong Chinese female.

ii The metric or method of measurement used

Associations between these risk factors and current fertility status will be examined by univariate (logistic regression) and multivariate (discriminant) analyses.

iii The timepoint(s) of primary interest

NA

24 Secondary Outcome

i The Name of the outcome

NA

ii The metric or method of measurement used

NA

iii The timepoint(s) of primary interest

NA

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-12-09

27 Primary Registry and Trial Identifying Number

ChiCTR1900021049

28 Date of Registration in Primary Registry

2019-01-04

Back History

Trial Detail