Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00539

2 Trial Registration Date

2016-12-20

i Registration Status

Prospective

3 Secondary IDs

2016.558

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

Cheung Wing Ching Cosy/ Tse Lai Yiu

ii Address

office 4, 1F, Block F,
Department of OG,
Prince of Wales Hospital,
30-32 Ngan Shing Street,
Shatin, N.T.
Hong Kong

iii Phone

26323199

iv Email

cosycheung@cuhk.edu.hk

v Affiliation

Obstetric and gynaecology, CUHK

vi Country

Hong Kong

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

i Name

YIU LEUNG CHAN

ii Address

office 4, 1F, Block F,
Department of OG,
Prince of Wales Hospital,
30-32 Ngan Shing Street,
Shatin, N.T.
Hong Kong

iii Phone

26323199

iv Email

cylcps@yahoo.com.hk

v Affiliation

Obstetric and gynaecology, CUHK

vi Country

Hong Kong

9 Official Scientific Title of the Study

The effect of physical activity on sperm quality

10 Public Title

The effect of physical activity on sperm quality

i Public Title in Chinese 研究名稱

身體活動對精子質素的影響

11 Short Title (Optional)

The effect of physical activity on sperm quality

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?

2016-11-29

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.558

14 Medical Condition Being Studied

Sperm quality

physical activity

15 Intervention

i Types of intervention

Other

Please specify

no intervention will be provided.

ii Description/ name of Intervention/article

all the participant will be provided a portable accelerometer for 7 days to measure their activity activity

iii Dosage form of the intervention

This is not a drug trial

iv Dosage of the intervention

This is not a drug trial

v Duration of the intervention

This is not a drug trial

vi Frequency of the intervention

This is not a drug trial

16 Comparative Treatments

i Description/ name of comparative treatments

There is no comparative treatments. All the participant will be provided a portable accelerometer for 7 days to measure their activity activity

ii Dosage form of the comparative treatments

This is not a drug trial

iii Dosage of the comparative treatments

This is not a drug trial

iv Duration of the comparative treatments

This is not a drug trial

v Frequency of the comparative treatments

This is not a drug trial

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Non azoospermic

No known genetic defects

ii Exclusion Criteria

azoospermic

Phenotypically abnormal

iii Age Minimum

18

iv Age Maximum

75

v Gender

Male

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

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

This is not a drug trial

vi Study Objectives (Optional)

The aim of this study is to investigate the relations between PA and semen quality in a given period in order to understand underlying mechanism on fluctuation in different semen parameters.

20 Anticipated trial start date

2016-12-26

21 Target Sample Size

200

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

measure intensity of physical activity (PA)

ii The metric or method of measurement used

a portable accelerometer will be provided for 7 days to measure PA

iii The timepoint(s) of primary interest

7 days

24 Secondary Outcome

i The Name of the outcome

semen quality

ii The metric or method of measurement used

semen analysis

iii The timepoint(s) of primary interest

day of recruitment and after 7 days of recruitment

Secondary Outcome

i The Name of the outcome

measure hormonal testing and other biochemical molecules such as enzyme or amino acid

ii The metric or method of measurement used

blood sampling ( 5 - 10 ml blood)

iii The timepoint(s) of primary interest

day of recruitment and after 7 days of recruitment

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-10-30

27 Primary Registry and Trial Identifying Number

ChiCTR-ROC-16010246

28 Date of Registration in Primary Registry

2016-12-20

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Trial History Detail on 2019-07-02