Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00443

2 Trial Registration Date

2015-01-20

i Registration Status

Prospective

3 Secondary IDs

CRE-2014.509

4 Source(s) of Funding

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

5 Primary Sponsor

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

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

Department of Obstetrics &Gynaecology, Prince of Wales Hospital

vi Country

Hong Kong

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

i Name

Dr. Grace Kong

ii Address

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

iii Phone

2632 2996

iv Email

gracekong@cuhk.edu.hk

v Affiliation

Department of Obstetrics &Gynaecology, Prince of Wales Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

Evaluation of Anti-Mullerian Hormone as a predictive marker in ovarian reserve and assisted reproductive technology

10 Public Title

Evaluation of Anti-Mullerian Hormone as a predictive marker in ovarian reserve and assisted reproductive technology

i Public Title in Chinese 研究名稱

評估以AMH作為預測卵巢功能和輔助生殖技術中卵巢反應的指標

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?

2014-11-11

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CRE-2014.509

14 Medical Condition Being Studied

women undergoing IVF cycles

15 Intervention

i Types of intervention

Other

Please specify

blood takeing

ii Description/ name of Intervention/article

5 ml of blood will be collected for AMH test.

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

5 mins.

vi Frequency of the intervention

nil

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

infertility women who attend Assisted Reproductive Technology centre, Prince of Wales Hospital for In-vitro fertilization (IVF) programme

ii Exclusion Criteria

patients who are unwilling to participate

iii Age Minimum

18

iv Age Maximum

45

v Gender

Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Uncontrolled

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

2015-02-01

21 Target Sample Size

200

22 Recruitment Status

Recruiting

23 Primary Outcome

To determine the efficacy of AMH to predict the poor ovarian responder and over ovarian responder.

24 Secondary Outcome

To study the relationship between AMH and the ovarian response after ovarian stimulation in IVF cycle
To study the relationship between AMH and other baseline ovarian reserve markers on assessing the ovarian reserve and ovarian response in IVF cycle

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-07-06

27 Primary Registry and Trial Identifying Number

ChiCTR-OOC-15005867

28 Date of Registration in Primary Registry

2015-01-23

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Trial History Detail on 2017-01-20