Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00580

2 Trial Registration Date

2018-01-17

i Registration Status

Prospective

3 Secondary IDs

2017.013

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

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

1F, 1 floor, EF Block (Special Block), Department of OG, Prince of Wales Hospital, Shatin

iii Phone

3505 1764

iv Email

cosycheung@cuhk.edu.hk

v Affiliation

Department of OG

vi Country

Hong Kong

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

i Name

YIU LEUNG CHAN

ii Address

1F, 1 floor, EF Block (Special Block), Department of OG, Prince of Wales Hospital, Shatin

iii Phone

3505 3199

iv Email

cylcps@yahoo.com.hk

v Affiliation

Obstetric and gynaecology, CUHK

vi Country

Hong Kong

9 Official Scientific Title of the Study

A study on the relation between semen quality, compositions and microflora in male HBV carriers

10 Public Title

A study on the relation between semen quality, compositions and microflora in male HBV carriers

i Public Title in Chinese 研究名稱

男性乙型肝炎攜帶者的精液質量、組合物和微生物群落之間的關係

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?

2017-03-14

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.013

14 Medical Condition Being Studied

Hepatitis B virus (HBV) carrier

semen quality

semen composition

semen microflora

15 Intervention

i Types of intervention

Other

Please specify

semen analysis, blood taking and filling in questionnaires

ii Description/ name of Intervention/article

1. provide a semen sample (A portion of semen will be taken for routine analysis, rest of the sample is for research purposes).
2. take 5 – 10ml blood sample for hormonal test or other biochemical molecules (such as enzyme or amino acid). Blood taking may cause minimal pain and very minimal risk of infection.
3. Spend 5 – 10 minutes to fill in the questionnaire.

iii Dosage form of the intervention

Nil

iv Dosage of the intervention

Nil

v Duration of the intervention

Nil

vi Frequency of the intervention

Nil

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

Chinese male

HBV carrier

40 non HBV carriers will also be recruited as a group of control.

ii Exclusion Criteria

genetic defects (Phenotypically abnormal)

azoospermia

iii Age Minimum

18

iv Age Maximum

60

v Gender

Male

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

This is not a drug trial

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-01-23

21 Target Sample Size

307 HBV carrier & 40 healthy non HBV patients: totally 347

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

To find out what is/are the major factor/s impair male fertility in chronical HBV carriers.

ii The metric or method of measurement used

semen sampling, blood sampling and filling in a questionnaire about lifestyle

iii The timepoint(s) of primary interest

(1) at the day of semen analysis, (2) follow up for fertility outcome

24 Secondary Outcome

i The Name of the outcome

Possibly minimize the viral infection/transmission outcome and maximize subfertility treatment outcome among male HBV carriers

ii The metric or method of measurement used

semen sampling, blood sampling and filling in a questionnaire about lifestyle

iii The timepoint(s) of primary interest

(1) at the day of semen analysis, (2) follow up for fertility outcome

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-07-06

27 Primary Registry and Trial Identifying Number

ChiCTR1800014628

28 Date of Registration in Primary Registry

2018-01-18

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Trial History Detail on 2019-07-02