Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00496

2 Trial Registration Date

2016-01-04

i Registration Status

Prospective

3 Secondary IDs

2015.534

4 Source(s) of Funding

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

5 Primary Sponsor

Department of Obstetric 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

cheung wing ching

ii Address

Office 4, 1 Floor, E Block (Special Block),
Department of Obstetric and Gynaecology,
Princes Wales Hospital,
30-32 Ngan Shing Street, Shatin, N.T.

iii Phone

35053199

iv Email

cosycheung@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong China

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

i Name

Prof Li Tin Chiu

ii Address

1 Floor, F Block (Special Block),
Department of Obstetric and Gynaecology,
Princes Wales Hospital,
30-32 Ngan Shing Street, Shatin, N.T.

iii Phone

3505 2800

iv Email

tinchiu.li@cuhk.edu.hk

v Affiliation

CUHK

vi Country

HONG KONG CHINA

9 Official Scientific Title of the Study

The association between psychological and physical stress and clinical outcomes in couples undergoing treatment for infertility

10 Public Title

The association between psychological and physical stress and clinical outcomes in couples undergoing treatment for infertility

i Public Title in Chinese 研究名稱

夫婦接受不孕治療的心理和生理上壓力和臨床結果之間的關聯

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?

2015-11-17

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.534

14 Medical Condition Being Studied

psychological stress and physical stress

15 Intervention

i Types of intervention

Other

Please specify

This study only require participants to provide salivary specimens and fill in questionnaires.

ii Description/ name of Intervention/article

This study only require participants to provide salivary specimens and fill in questionnaires. Intervention is not required.

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

This study only require participants to provide salivary specimens and fill in questionnaires. No comparative treatment is required

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

Couples with reproductive failure undergoing IVF treatment

ii Exclusion Criteria

History of psychological/ psychiatric problem

History of smoking, physical exercise, meals, alcoholic beverages and low pH drinks at least 1 hour prior to testing

Patient refusal

iii Age Minimum

18

iv Age Maximum

40

v Gender

Both Male and Female

18 Study Type

Observational

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

Other

Please specify

not a drug study

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-01-11

21 Target Sample Size

350

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Does psychological and physical stress, as measured via structured questionnaires and stress biomarkers correlate with clinical outcomes (i.e. implantation rate, pregnancy rate and miscarriage rate) following IVF treatment?

ii The metric or method of measurement used

provide salivary specimens and fill in questionnaires

iii The timepoint(s) of primary interest

at least 3 time-points during their IVF treatment: (1) at least 15 minutes before the embryo transfer (baseline), (2) immediately after embryo transfer, and (3) just before the pregnancy test or scan.

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

2018-11-30

27 Primary Registry and Trial Identifying Number

ChiCTR-OOC-16007880

28 Date of Registration in Primary Registry

2016-02-02

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Trial History Detail on 2017-11-09