Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00497

2 Trial Registration Date

2016-01-04

i Registration Status

Prospective

3 Secondary IDs

CRE-2015.477

4 Source(s) of Funding

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

5 Primary Sponsor

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

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/ Cosy Cheung

ii Address

1/F Block F, Prince of Wales Hospital, Shating, NT

iii Phone

26321764

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, Prince of Wales Hospital, Shating, NT

iii Phone

2632 2800

iv Email

tinchiu.li@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong

9 Official Scientific Title of the Study

Role of chronic endometritis in reproductive failure

10 Public Title

Role of chronic endometritis in reproductive failure

i Public Title in Chinese 研究名稱

慢性子宮內膜炎在生殖障礙中作用的研究

11 Short Title (Optional)

Role of chronic endometritis in reproductive failure

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?

2015-09-22

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.477

14 Medical Condition Being Studied

Women with recurrent miscarriage, recurrent implantation failure, or with infertility undergoing IVF treatment .

15 Intervention

i Types of intervention

Other

Please specify

None

ii Description/ name of Intervention/article

This project is an observational one. During the study, the procedure would be the same as per current practice,except saving two inner catheters instead of one.

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

NA

vi Frequency of the intervention

NA

16 Comparative Treatments

i Description/ name of comparative treatments

NA

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Age 20-40 years.

Women with recurrent miscarriage, recurrent implantation failure, or with infertility undergoing IVF treatment .

ii Exclusion Criteria

Uncorrected uterine anomalies, such as septate or bicornuate uterus, fibroids (submucous/intramural).

Intrauterine adhesions.

Adenomyosis.

Systematic disease that may cause subfertility, such as diabetes or systemic lupus erythematosus.

iii Age Minimum

20

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

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-01-15

21 Target Sample Size

300

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

We will conduct a retrospective analysis of endometrial response to infection as measured by plasma cell count, uNK cell count and Toll like receptor expression in archived endometrial tissue specimen from several groups of women with reproductive failure. At the same time, a prospective study to ex

ii The metric or method of measurement used

To examine markers of tissue response to infection including plasma cell count, uterine natural killer cell (uNK) count and Toll like receptor expression.

iii The timepoint(s) of primary interest

NA

24 Secondary Outcome

i The Name of the outcome

Microbiome in uterine fluid at time of ET will be examined, as well as correlate findings with the various clinical outcomes of ET.

ii The metric or method of measurement used

DNA extraction,PCR amplification,Next-generation sequencing

iii The timepoint(s) of primary interest

NA

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

ChiCTR-IOC-16007882

28 Date of Registration in Primary Registry

2016-02-02

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Trial History Detail on 2017-01-20