Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00369

2 Trial Registration Date

2013-05-14

iRegistration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

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

5 Primary Sponsor

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

6 Secondary Sponsor

Nil

Function

Please specify

7Responsible Contact Person (public contact person for patients interested in participating)

i Name

TSE Lai Yiu

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

Nil

vi Country

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

i Name

Dr Mak Sze Man Jennifer

ii Address

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

iii Phone

2632 1764

iv Email

jennifermak@cuhk.edu.hk

v Affiliation

Nil

vi Country

9 Official Scientific Title of the Study

Follicular fluid hepatitis B viral level in female Hepatitis B carriers seeking in-vitro fertilization (IVF) therapy and treatment outcome: a prospective observational study

10 Public Title

Follicular fluid hepatitis B viral level in female Hepatitis B carriers seeking in-vitro fertilization (IVF) therapy and treatment outcome: a prospective observational study

i Public Title in Chinese 研究名稱

卵泡液中乙型肝炎病毒含量及其對輔助生育(試管嬰兒)懷孕率之影響調查研究

11 Short Title (Optional)

Follicular fluid hepatitis B viral level in female Hepatitis B carriers seeking in-vitro fertilization (IVF) therapy and treatment outcome

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-04-09

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

in-vitro fertilization; Hepatitis B; follicular fluid

15Intervention

i Types of intervention

Other

Please specify

Nil

ii Description/ name of Intervention/article

N/A

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

N/A

vi Frequency of the intervention

16Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Women screened positive for HBsAg prior to IVF treatment

ii Exclusion Criteria

Women with clinical manifestation of Hepatitis B infection, with other blood borne infection including Hepatits C, HIV, syphilis, partner is also a hepatitis B carrier and those who unable to give consent or refuse to participate in the study

iii Age Minimum

18

iv Age Maximum

45

v Gender

Female

18 Study Type

Observational

19Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-06-01

21 Target Sample Size

131

22 Recruitment Status

Recruiting

23 Primary Outcome

Clincal pregnancy rate
Follicular fluid HBV DNA level

24 Secondary Outcome

N/A

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2017-11-14

27 Primary Registry and Trial Identifying Number

ChiCTR-ONC-13003218

28 Date of Registration in Primary Registry

2013-05-16

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2015-07-07