Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00333

2 Trial Registration Date

2012-09-07

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

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Carol Chan

ii Address

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

iii Phone

26321764

iv Email

carolchan@cuhk.edu.hk

v Affiliation

CUHK

vi Country

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

i Name

Dr. Wai Yee Wong

ii Address

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

iii Phone

26322583

iv Email

alicewywong@cuhk.edu.hk

v Affiliation

CUHK

vi Country

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

13Research 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

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

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

15Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

4D HyCoSy

iii Dosage form of the intervention

iv Dosage of the intervention

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

16Comparative Treatments

i Description/ name of comparative treatments

2D HyCoSy

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

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

19Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

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

2012-10-15

21 Target Sample Size

100

22 Recruitment Status

Not Yet Recruiting

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).

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2018-11-30

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2012-09-07