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Trial Detail

CUHK_CCRB00524

2016-08-23

Prospective

2016.127

NA

NA

NA

Not Applicable

CHEUNG WING CHING

Office 4, 1F, 1 Floor, Block F, Princes Wales of Hospital, 30-32 Ngan Shing Street, Shatin, N.T. Hong Kong

26321764

cosycheung@cuhk.edu.hk

Obstetrics and Gynaecology, the Chinese University of Hong Kong

Hong Kong

JIN HUANG

Office 4, 1F, 1 Floor, Block F, Princes Wales of Hospital, 30-32 Ngan Shing Street, Shatin, N.T. Hong Kong

26323199

huangj@cuhk.edu.hk

Obstetrics and Gynaecology, the Chinese University of Hong Kong

Hong Kong

Biomarkers in prediction of endometrium receptivity

Biomarkers in prediction of endometrium receptivity

預測子宮內膜容受性標誌物的研究

預測子宮內膜容受性標誌物的研究

Hong Kong

Yes

2016-05-26

Joint CUHK-NTEC Clinical Research Ethics Committee

2016.127

endometrium receptivity, implantation failure, genomic markers

Procedure

Endometrial scratch (biopsy) will be performed in the luteal phase, 7 days after spontaneous LH surge preceding menstrual cycle before frozen embryo transfer (FET). Endometrial scratch will be performed with the use of a Pipelle endometrial sampler (Paris, France) as follows: the Pipelle is inserted through the cervical os and advanced gently until resistance is felt. The inner piton of the device is then withdrawn to create suction, the superficial layers of the endometrium is then “scratched” by moving the tipoff the Pipelle sampler up and down within the uterine cavity, at the same time the device is rotated 360° to ensure adequate coverage of the entire surface of the endometrium.

This is not a drug trial

This is not a drug trial

The whole procedure will take a few minutes

Endometrial scratch will be performed in the luteal phase, 7 days after spontaneous LH surge.

no comparative treatment will be performed

no comparative treatment will be performed

no comparative treatment will be performed

no comparative treatment will be performed

no comparative treatment will be performed

Women undergoing natural cycle frozen-thawed embryo transfer (FET) will be recruited from the IVF unit at the Prince of Wales Hospital, Chinese University of Hong Kong.

uterine pathology such as endometrial polyp, submucous fibroid, intra-uterine adhesions or congenital uterine anomalies

18

55

Female

Observational

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Other

this is not a drug trial

1. examine endometrial specimens obtained from endometrial scratch to determine if any of the biochemical or genomic markers could predict the outcome of embryo transfer treatment. 2. determine if the biochemical and genomic markers of endometrial specimens in women who are tested positive HBV

2016-09-30

100

Recruiting

Endometrial scratch (biopsy)

The endometrium will be divided into two portions. One portion will be fixed in formalin and processed for histological analysis and immunohistochemical analysis. The second portion will be snap frozen for RNA extraction and genomic analysis.

Endometrial scratch (biopsy) will be performed in the luteal phase, 7 days after spontaneous LH surge preceding menstrual cycle before FET. Endometrial scratch will be performed.

Natural cycle frozen-thawed embryo transfer (FET)

. Spontaneous ovulation is confirmed by daily LH and estradiol measurement from day 9 onwards and ultrasound examination around the time fo the LH surge.

Spontaneous ovulation is confirmed by daily LH and estradiol measurement from day 9 onwards

Outcome of treatment

A pregnancy test will be performed 9 to 11 days after embryo transfer. If the test is positive, transvaginal ultrasound of the uterus will be performed two weeks later to assess the location, number, and viability of the pregnancy.

A pregnancy test will be performed 9 to 11 days after embryo transfer.

No

2016-10-18

ChiCTR-COC-16009067

2016-08-23

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