Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00649

2 Trial Registration Date

2018-12-18

i Registration Status

Prospective

3 Secondary IDs

2018.365

4 Source(s) of Funding

N/A

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Cheung Wing Ching

ii Address

office 4, 1 F, EF Block (Special Block), PWH

iii Phone

35051764

iv Email

cosycheung@cuhk.edu.hk

v Affiliation

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

vi Country

China

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

i Name

Xiaoyan Chen

ii Address

office 4, 1 F, EF Block (Special Block), PWH

iii Phone

59334979

iv Email

chenxiaoyan@cuhk.edu.hk

v Affiliation

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

vi Country

China

9 Official Scientific Title of the Study

Do endometrial leucocytes and angiogenesis in the peri-implantation period predict hypertensive disorders in the subsequent pregnancy?

10 Public Title

Do endometrial leucocytes and angiogenesis in the peri-implantation period predict hypertensive disorders in the subsequent pregnancy?

i Public Title in Chinese 研究名稱

子宮內膜白細胞和植入前期血管生成是否能預測隨後妊娠期的高血壓疾病？

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-10-05

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.365

14 Medical Condition Being Studied

hypertensive disorders

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

All the subjects will have daily urine test from day 9 of the menstrual cycle to identify the Luteinizing Hormone (LH) surge. Endometrial biopsy will be obtained precisely 7 days after LH surge (LH+7). The biopsy will be performed by gynaecologist. Endometrial samples will be obtained using a Pipelle sampler as an outpatient procedure. The procedure may cause some abdominal pain, bleeding and small risk of infection and uterine perforation.
The endometrium specimen will be divided into two proportions: 1) one proportion will be fixed in 4% formalin for 24 hours, routinely processed and embedded in paraffin wax; 2) another proportion will be rinsed immediately and then snap frozen-stored for further analysis if needed.

iii Dosage form of the intervention

one time of endometrial biopsy

iv Dosage of the intervention

one time of endometrial biopsy

v Duration of the intervention

one time of endometrial biopsy

vi Frequency of the intervention

one time of endometrial biopsy ( precisely 7 days after LH surge)

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Women with a history of reproductive failure, including infertility, recurrent implantation failure and recurrent miscarriage

2. Women younger than 40 years old

ii Exclusion Criteria

1. Women who have any uterine anomaly (such as fibroid and adenomyosis) or intrauterine pathology (such as polyp and intrauterine adhesion);

2. Hydrosalpinx

3. Women diagnosed as hypertension prior to the endometrial biopsy

4. On aspirin or steroid treatment

5. Diabetes

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)

The aim of this study is to investigate whether or not endometrial leucocytes and angiogenesis markers in the peri-implantation endometrium are associated with an increased risk of hypertensive disorders in a subsequent pregnancy.

20 Anticipated trial start date

2018-12-27

21 Target Sample Size

690

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

the presence of uNK cells

ii The metric or method of measurement used

Immunohistochemistry staining

iii The timepoint(s) of primary interest

Endometrial biopsy will be obtained precisely 7 days after LH surge

Primary Outcome

i The Name of the outcome

pregnancy outcome

ii The metric or method of measurement used

The subjects will be assessed: (1) any gestational hypertension and (2) pregnancy history (e.g. live birth and miscarriage etc)

iii The timepoint(s) of primary interest

All the subjects will be followed up for their subsequent pregnancy outcome within a year following the endometrial biopsy.

24 Secondary Outcome

i The Name of the outcome

endometrial markers

ii The metric or method of measurement used

Multiplex immunofluorescence panel

iii The timepoint(s) of primary interest

Endometrial biopsy will be obtained precisely 7 days after LH surge

Secondary Outcome

i The Name of the outcome

hormonal and biochemical molecules

ii The metric or method of measurement used

blood sampling

iii The timepoint(s) of primary interest

7 days after LH surge

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-07-21

27 Primary Registry and Trial Identifying Number

ChiCTR1900021046

28 Date of Registration in Primary Registry

2018-12-18

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Trial History Detail on 2019-01-29