Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00577

2 Trial Registration Date

2018-01-11

i Registration Status

Prospective

3 Secondary IDs

2017.133

4 Source(s) of Funding

Nil

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

Cheung Wing Ching

ii Address

1E, 1 Floor, EF Block (Special Block), Department of OG, Prince of Wales, Shatin, N.T.

iii Phone

3505 1764

iv Email

cosycheung@cuhk.edu.hk

v Affiliation

Department of OG

vi Country

Hong Kong

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

i Name

Dr. CHUNG Pui Wah, Jacqueline

ii Address

1F, 1 Floor, EF Block (Special Block), Department of OG, Prince of Wales, Shatin, N.T.

iii Phone

35051537

iv Email

jacquelinechung@cuhk.edu.hk

v Affiliation

Department of OG

vi Country

Hong Kong

9 Official Scientific Title of the Study

Adenomyosis in infertility patients and those with recurrent implantation failure

10 Public Title

Adenomyosis in infertility patients and those with recurrent implantation failure

i Public Title in Chinese 研究名稱

子宮腺肌症對不孕及體外受精之影響

11 Short Title (Optional)

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?

2017-04-01

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.133

14 Medical Condition Being Studied

Adenomyosis

recurrent implantation failure

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

1. 2D/ 3D transvaginal ultrasound examination or magnetic resonance imaging (MRI) will be performed to examine the uterus, ovaries and adenxal region.

2. Depending on clinical condition of individual patient, some may have to undergo further assessment with hysteroscopy and endometrial sampling. T

2.1 Patient will also be asked to come back for an endometrial sampling for endometrial assessment during 7 days after the LH surge (as detected using urine LH kit).

2.2 Hysteroscopy is a common gynaecological examination. The procedure will be performed under aseptic technique.

iii Dosage form of the intervention

nil

iv Dosage of the intervention

nil

v Duration of the intervention

nil

vi Frequency of the intervention

nil

16 Comparative Treatments

i Description/ name of comparative treatments

nil

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

18 to 45 years old

a diagnosis of clinically suspected and ultrasound/MRI diagnosis adenomyosis undergoing ART treatment

ii Exclusion Criteria

previous uterine surgery

uterine malformation

endometrial abnormalities like those with endometrial polyps, fibroids

refuse to join

iii Age Minimum

18

iv Age Maximum

45

v Gender

Female

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)

20 Anticipated trial start date

2018-01-17

21 Target Sample Size

50

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

explore the relationship between adenomyosis and recurrent implantation failure.

ii The metric or method of measurement used

(1) 2D/3D Ultrasound or MRI, (2) Hysteroscopy, (3) Endometrial sampling

iii The timepoint(s) of primary interest

(1) & (2): ultrasound/ MRI and hysteroscopy will be performed by individual schedule, (3) Endometrial sampling: LH surge + 7 days

Primary Outcome

i The Name of the outcome

evaluate the overall incidence of adenomyosis in patient undergoing IVF treatment

ii The metric or method of measurement used

(1) 2D/3D Ultrasound or MRI, (2) Hysteroscopy, (3) Endometrial sampling

iii The timepoint(s) of primary interest

(1) & (2): ultrasound/ MRI and hysteroscopy will be performed by individual schedule, (3) Endometrial sampling: LH surge + 7 days

24 Secondary Outcome

i The Name of the outcome

evaluate the IVF stimulation, laboratory and reproductive outcome of those patients with adenomyosis, especially in those with recurrent implantation failure.

ii The metric or method of measurement used

(1) Demographic data and detailed clinical history will be recorded, (2) 2D/3D transvaginal or magnetic resonance imaging

iii The timepoint(s) of primary interest

(1) At the time of recruitment, (2) ultrasound/ MRI will be performed by individual schedule

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-07-06

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-01-11