Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00323

2 Trial Registration Date

2012-07-19

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

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

5 Primary Sponsor

Nil

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

ii Address

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

iii Phone

26321764

iv Email

eristse@cuhk.edu.hk

v Affiliation

Nil

vi Country

Hong Kong

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

i Name

Prof Wing Shan Kong

ii Address

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

iii Phone

26322996

iv Email

gracekong@cuhk.edu.hk

v Affiliation

Nil

vi Country

Hong Kong

9 Official Scientific Title of the Study

The effect of local injury to the endometrium on pregnancy rate for patients undergoing natural-cycle frozen-thawed embryo transfer: a randomized study

10 Public Title

The effect of local injury to the endometrium on pregnancy rate for patients undergoing natural-cycle frozen-thawed embryo transfer: a randomized study

i Public Title in Chinese 研究名稱

子宮內膜抽取對自然週期凍融胚胎移植之調查研究

11 Short Title (Optional)

Nil

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?

2012-02-07

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2011.531.T

14 Medical Condition Being Studied

All natural cycle frozen-thawed embryo transfer (FET) cycles using non donor oocytes will be recruited

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Endometrial biopsy

iii Dosage form of the intervention

na

iv Dosage of the intervention

na

v Duration of the intervention

Endometrial biopsy will be performed in the experimental group at the luteal phase on the days 21-26

vi Frequency of the intervention

once

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

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

All natural cycle frozen-thawed embryo transfer (FET) cycles using non donor oocytes will be recruited

ii Exclusion Criteria

Patients who had any uterine anomaly or pathology such as endometrial polyp, endometriomas with a diameter >4 cm, and visible hydrosalpinx on transvaginal ultrasound scans will be excluded.

iii Age Minimum

18

iv Age Maximum

40

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

na

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-09-01

21 Target Sample Size

206

22 Recruitment Status

Recruiting

23 Primary Outcome

Pregnancy and implantation rate.

24 Secondary Outcome

The clinical and ongoing pregnancy rates

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-06-05

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-12002389

28 Date of Registration in Primary Registry

2012-08-05

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Trial History Detail on 2016-07-13