Prospective

CHEUNG WING CHING/ TSZ LAI YIU

1/F, Special Block (Block F), Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, N.T. Hong Kong

2632 1764

cosycheung@cuhk.edu.hk

Department of Obstetric & Gynaecology

Hong Kong

Lai-ping Cheung

1/F, Special Block (Block E), Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, N.T. Hong Kong

(852)91869883

lpcheung@cuhk.edu.hk

Department of Obsterics & Gynaecology, The Chinese University of Hong Kong

Hong Kong

多囊卵巢綜合症患者與對照組子宮內膜及外周血轉錄組同妊娠結局差異的研究

Yes

2015-08-11

Joint CUHK-NTEC Clinical Research Ethics Committee

2015.325

Other

endometrium and blood sampling

Endometrial biopsy and peripheral blood will be obtained from women with PCOS and from controls, either 7 days after the LH surge (day LH+7, where LH+0 is the day of the LH surge) in natural ovulatory cycle, or 5 days after progesterone administration in HRT cycle (day P+5) which is equivalent to day LH+7. In all cases, endometrial biopsies will be obtained in the cycle immediately preceding the planned IVF or FET treatment cycle as there is preliminary evidence that endometrial biopsy procedure (endometrial scratch) in the luteal phase before embryo transfer cycle may help to improve implantation rate.

NA

NA

7 days after the LH surge (day LH+7)

NA

As PCOS may be ovulatory or anovulatory, there will be 2 comparison groups; the subjects and the controls will be matched with age groups and BMI groups.
1) Ovulatory PCOS patients will be compared to ovulatory fertile controls that have given birth to one or more babies.
2) In non-ovulatory subjects, it is necessary to administer hormone therapy to convert the endometrium to a receptive state. Anovulatory PCOS patients will be compared to non-PCOS controls undergoing ART treatment. In both groups, a standardized hormone replacement therapy (HRT) regime will be administered in the cycle preceding the in vitro fertilization (IVF) or frozen-thawed embryo replacement (FET) treatment. The HRT regimen consists of oral oestradiol 6 mg daily starting on cycle day 3, with addition of vaginal endometrin 100 mg twice daily after 14-16 days of estradiol, and both to continue till the end of the cycle day 30.

Endometrial biopsy and peripheral blood will be obtained from women with PCOS and from controls, either 7 days after the LH surge (day LH+7, where LH+0 is the day of the LH surge) in natural ovulatory cycle, or 5 days after progesterone administration in HRT cycle (day P+5) which is equivalent to day LH+7.

NA

NA

7 days after the LH surge (day LH+7)

NA

• Infertile PCOS women with age < 40 undergoing assisted reproductive technology (ART) treatment. The diagnosis of PCOS is based on the Rotterdam criteria (2003), briefly: 2 out of 3 criteria after exclusion of other aetiologies. 1) Oligo-amenorrhoea/ chronic anovulation; 2) Clinical and/or biochemical hyperandrogenism; 3) Ultrasound features of polycystic ovaries.

(1) Uncorrected uterine pathologies such as congenital uterine anomalies, intrauterine adhesions, adenomyosis, fibroids, endometrial polyp

(2) Hydrosalpinx

18

40

Female

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Other

This is not a drug trial

To compare the changing pattern of peripheral blood transcriptome profile for a period of 5 weeks following embryo transfer between PCOS women and non-PCOS controls receiving ART treatment; and to correlate the results to the outcomes of pregnancy (no conception, conceived but followed by biochemi

No