Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00313

2 Trial Registration Date

2012-02-03

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

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Carol Chan

ii Address

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

iii Phone

26321764

iv Email

carolchan@cuhk.edu.hk

v Affiliation

Nil

vi Country

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

i Name

Dr. Wai Yee Wong

ii Address

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

iii Phone

26322583

iv Email

alicewywong@cuhk.edu.hk

v Affiliation

Nil

vi Country

9 Official Scientific Title of the Study

Ovarian response in poor ovarian responder: a randomized controlled trial on the effect of mid-follicular phase recombinant luteinizing hormone versus low dose urinary human chorionic gonadotrophin supplement on in-vitro fertilization cycles.

10 Public Title

: Ovarian response in poor ovarian responder: a randomized controlled trial on the effect of mid-follicular phase recombinant luteinizing hormone versus low dose urinary human chorionic gonadotrophin supplement on in-vitro fertilization cycles.

i Public Title in Chinese 研究名稱

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?

2011-11-08

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

women undergoing IVF-ET cycles

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Subcutaneous injection of rLH or uhCG injection

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Subcutaneous injection of rLH or uhCG injection since day 6 of ovarian stimulation in IVF cycles un

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Nil

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. History of 2 episodes of poor ovarian response (≤3 mature follicles on ovulatory dose of hCG or ≤3 mature oocytes retrieved) despite maximal stimulation; or
2. Patients fulfill two out of three of the following features:
I. Age ≥40 or any other risk factors
i. History of ovarian surgery
ii. History of salpingectomy
iii. History of chemotherapy
iv. Present of ovarian endometrioma
II. Previous poor ovarian response (≤3 mature follicles on ovulatory dose of hCG or ≤3 mature oocytes retrieved)
III. Abnormal ovarian reserve test
i. Follicle stimulating hormone(FSH) 10 mIU/L; or
ii. Antral follicle count (AFC) ≤7 follicules; or
iii. Anti-Müllerian hormone (AMH) ≤1.1 ng/ml

ii Exclusion Criteria

1. Body mass index≥30kg/m2
2. Absent of one ovary
3. History of polycystic ovarian disease
4. Present of uterine abnormalities
5. Present of endocrine/metabolic/autoimmune disease
6. Incompetence or refuse for informed consent

iii Age Minimum

18

iv Age Maximum

45

v Gender

Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-03-01

21 Target Sample Size

60

22 Recruitment Status

Recruiting

23 Primary Outcome

Number of mature oocytes retrieved on day of oocyte pick-up

24 Secondary Outcome

• Clinical pregnancy rates (defined as presence of intrauterine gestational sac with cardiac activity)
• Implantation rates (defined as number of gestational sacs / transferred embryos)
• Ongoing pregnancy rates (defined as pregnancy more than 12 weeks of gestation)
• Live birth rates (defined as delivery of live baby more than 24 weeks of gestation)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-07

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-12002072

28 Date of Registration in Primary Registry

2012-04-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2012-12-07