Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00495

2 Trial Registration Date

2016-01-04

i Registration Status

Prospective

3 Secondary IDs

CRE-2015.491

4 Source(s) of Funding

Department of Obstetrics and Gunaecology, The Chinese University of Hong Kong

5 Primary Sponsor

Department of Obstetrics and Gunaecology, 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

Tse Lai YIu/ Cosy Cheung

ii Address

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

iii Phone

26321764

iv Email

eristse@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

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

i Name

Prof Li Tin Chiu

ii Address

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

iii Phone

2632 2800

iv Email

tinchiu.li@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

9 Official Scientific Title of the Study

The relationship between serum lead level and semen parameters

10 Public Title

The relationship between serum lead level and semen parameters

i Public Title in Chinese 研究名稱

男性體內鉛含量與男性生育力相關性之研究

11 Short Title (Optional)

serum lead level, lead contamination, semen parameters, male fertility

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?

2015-10-09

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.491

14 Medical Condition Being Studied

The relationship between serum lead level and semen parameters

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Recruited subjects will be asked to complete a questionnaire and to have at least 10ml serum sample and about 3 g of hair taken for measurement of serum level and other confounding variables

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

6 months

vi Frequency of the intervention

Male subjects submitting a semen sample to the IVF unit for diagnostic evaluation or treatment purpo

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

Age below 50 years

No apparent cause of male infertility identified

ii Exclusion Criteria

1. Known systematic disease such as diabetes, systemic lupus erythematosus, chronic renal dysfunction, ect.

2. Smokes >20 cigarettes per day, drinks more than 20 units of alcohol per week.

iii Age Minimum

18

iv Age Maximum

50

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

Open label

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-01-15

21 Target Sample Size

400

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

s there a significant relationship between serum lead level and semen parameters/ treatment outcome?

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

s there a significant relationship between serum level of other heavy metal and environmental pollutants and semen parameters/ treatment outcome?

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-07-21

27 Primary Registry and Trial Identifying Number

ChiCTR-ROC-16007881

28 Date of Registration in Primary Registry

2016-02-02

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Trial History Detail on 2016-04-01