Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00333

2 Trial Registration Date

2012-09-07

i Registration 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

Nil

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

ii Address

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

iii Phone

35051764

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

3505 2800

iv Email

tinchiu.li@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

9 Official Scientific Title of the Study

The value of four-dimensional hystero-salpingo-contrast-sonography (HyCoSy) in the assessment of tubal patency

10 Public Title

The value of four-dimensional hystero-salpingo-contrast-sonography (HyCoSy) in the assessment of tubal patency

i Public Title in Chinese 研究名稱

經陰道子宮輸卵管四維超聲造影 (HyCoSy) 對輸卵管暢通性的診斷價值

11 Short Title (Optional)

Nil

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?

2012-08-17

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2012.323.t

14 Medical Condition Being Studied

Patient suffered from infertility and plan to undergo laparoscopy chromotubation for tubal assessment

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

4D HyCoSy

iii Dosage form of the intervention

nil

iv Dosage of the intervention

nil

v Duration of the intervention

4D HyCoSy will be carried out to the patient and the procedure will be done within 3 months prior to

vi Frequency of the intervention

nil

16 Comparative Treatments

i Description/ name of comparative treatments

2D HyCoSy

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

Patient suffered from infertility and plan to undergo laparoscopy chromotubation for tubal assessment

ii Exclusion Criteria

Present of uterine abnormalities or pelvis genital tract tumor. Present of acute pelvis inflammatory disease. Incompetence or refuse for informed consent.

iii Age Minimum

18

iv Age Maximum

40

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Randomized

Please specify

Randomization into two groups

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-10-15

21 Target Sample Size

100

22 Recruitment Status

Complete

23 Primary Outcome

Diagnostic accuracy of 2D or 4D HyCoSy as comparison of tubal patency between HyCoSy and gold standard laparoscopic chromotubation

24 Secondary Outcome

Experience of side effects and pain score during 2D or 4D HyCoSy by visual analogous scale will be recorded. Patient attitude towards the investigations will be assessed by an 8-item client satisfaction questionnaire (CSQ-8).

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-11-30

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-12002620

28 Date of Registration in Primary Registry

2012-10-26

Back History

Trial Detail