Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00540

2 Trial Registration Date

2016-12-20

i Registration Status

Prospective

3 Secondary IDs

2016.499

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, Department of OG,
Prince of Wales Hospital,
30 -32 Ngan Shing Street,
Shatin, Hong Kong

iii Phone

2632 3199

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, Department of OG,
Prince of Wales Hospital,
30 -32 Ngan Shing Street,
Shatin, 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

A study on the relation between semen compositions and chromatin status for better selection of sperm for in vitro fertilization

10 Public Title

A study on the relation between semen compositions and chromatin status for better selection of sperm for in vitro fertilization

i Public Title in Chinese 研究名稱

精液的組合物和染色質的之間的關係能否在體外受精中選擇出更好的精子

11 Short Title (Optional)

A study on the relation between semen compositions and chromatin status for better selection of sperm for in vitro fertilization

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?

2016-10-24

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.499

14 Medical Condition Being Studied

semen quality

semen composition

15 Intervention

i Types of intervention

Other

Please specify

This is not a drug trial.

ii Description/ name of Intervention/article

This is not a drug trial and there no intervention. semen composition will be measured

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. At the day of recruitment, a portion of semen will be taken from your seme

16 Comparative Treatments

i Description/ name of comparative treatments

This is not a drug trial and there no intervention. There is no comparative treatment

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

Have no children

ii Exclusion Criteria

Phenotypically abnormal

iii Age Minimum

18

iv Age Maximum

75

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)

The aim of this study is to investigate the relations between SP and DNA integrity in order to develop a better isolating method for sperm selection for IVF technologies.

20 Anticipated trial start date

2016-12-26

21 Target Sample Size

400

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

measure semen composition and chromatin status

ii The metric or method of measurement used

semen analysis

iii The timepoint(s) of primary interest

at the day of recruitment

24 Secondary Outcome

i The Name of the outcome

measure for hormonal and biochemical molecules

ii The metric or method of measurement used

blood sampling ( 5 - 10 ml blood)

iii The timepoint(s) of primary interest

at the day 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-16010247

28 Date of Registration in Primary Registry

2016-12-20

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Trial History Detail on 2018-06-26