Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00578

2 Trial Registration Date

2018-01-12

i Registration Status

Prospective

3 Secondary IDs

2016.673

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

1F, 1 Floor, EF block (special block), Department of OG, Prince of Wales Hospital, 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

Prof Li Tin Chiu

ii Address

1F, 1 Floor, EF block (special block), Department of OG, Prince of Wales Hospital, Shatin, N.T.

iii Phone

3505 2800

iv Email

tinchiu.li@cuhk.edu.hk

v Affiliation

Department of OG

vi Country

Hong Kong

9 Official Scientific Title of the Study

A study to compare the endometrial features of women who did and did not benefit from endometrial scratch in the cycle preceding frozen embryo transfer

10 Public Title

A study to compare the endometrial features of women who did and did not benefit from endometrial scratch in the cycle preceding frozen embryo transfer

i Public Title in Chinese 研究名稱

評估冷凍胚胎移植前子宮內膜搔刮對婦女子宮內膜特征影響之研究

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?

2017-01-26

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.673

14 Medical Condition Being Studied

infertility

endometrial features

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Several meta-analysis and a recent report from Cochrane database suggested that Mechanical endometrial injury (biopsy/scratch or hysteroscopy) performed sometime during the month before the start of ovarian stimulation could improve the chances that a woman will achieve live birth and clinical pregnancy although a recent RCT suggested endometrial injury in unselected subfertile women undergoing IVF did not appear to be beneficial. Consequently, it is necessary to identify and evaluate which group of women would benefit from endometrial scratch prior to IVF-ET treatment. In particular, there have been several RCTs examining the value of endometrial scratch in the luteal phase in women with unexplained RIF. Because of the difference in the method and timing used for inducing injury, there is considerable heterogeneity in the studies. The overall conclusion of these studies suggests that endometrial scratch is beneficial in women with RIF but should be carried out around the time of embryo implantation, and endometrial scratch could simply be performed by the use of a pipelle endometrial biopsy sampler. Several recent systematic reviews and meta-analyses showed a significant improvement in clinical pregnancy rate after endometrial scratch in women with RIF but suggested further robust randomized trials.

iii Dosage form of the intervention

Nil

iv Dosage of the intervention

Nil

v Duration of the intervention

once

vi Frequency of the intervention

Luteinization Hormone (LH) surge + 7 days

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

Women undergoing frozen embryo transfer cycles who fulfilled the diagnostic criteria for recurrent implantation failure

ii Exclusion Criteria

Women older than 40 years

Women who have any uterine anomaly or intrauterine pathology such as: Endometrial polyp

Large fibroid with a diameter >4 cm

Visible hydrosalpinx on transvaginal ultrasound scans

BMI >35

iii Age Minimum

18

iv Age Maximum

40

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

2018-01-18

21 Target Sample Size

120

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

examine uterine endometrial markers and association with subsequent IVF outcome

ii The metric or method of measurement used

Endometrial biopsy for immunohistochemistry, immunofluorescence and transcriptome study

iii The timepoint(s) of primary interest

LH + 7 days

24 Secondary Outcome

i The Name of the outcome

nil

ii The metric or method of measurement used

nil

iii The timepoint(s) of primary interest

nil

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

ChiCTR1800014443

28 Date of Registration in Primary Registry

2018-01-12

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Trial History Detail on 2019-07-02