CCRB Logo

Trial Detail

CUHK_CCRB00649

2018-12-18

Prospective

2018.365

N/A

N/A

N/A

Not Applicable

Cheung Wing Ching

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

35051764

cosycheung@cuhk.edu.hk

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

China

Xiaoyan Chen

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

59334979

chenxiaoyan@cuhk.edu.hk

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

China

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

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

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?

Hong Kong China

Yes

2018-10-05

Joint CUHK-NTEC Clinical Research Ethics Committee

2018.365

hypertensive disorders

Procedure

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.

one time of endometrial biopsy

one time of endometrial biopsy

one time of endometrial biopsy

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

N/A

N/A

N/A

N/A

N/A

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

2. Women younger than 40 years old

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

18

40

Female

Observational

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Other

This is not a drug trial

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.

2018-12-27

690

Recruiting

the presence of uNK cells

Immunohistochemistry staining

Endometrial biopsy will be obtained precisely 7 days after LH surge

pregnancy outcome

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

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

endometrial markers

Multiplex immunofluorescence panel

Endometrial biopsy will be obtained precisely 7 days after LH surge

hormonal and biochemical molecules

blood sampling

7 days after LH surge

No

2020-07-21

ChiCTR1900021046

2018-12-18

Type Document Published On  
No documents yet.
  • Page 1 of 1.