Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000200381
Ethics application status
Approved
Date submitted
11/04/2008
Date registered
14/04/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of early luteal phase vaginal progesterone supplementation on the outcome of in-vitro fertilization and embryo transfer
Scientific title
Effects of early luteal phase vaginal progesterone supplementation on the outcome of in-vitro fertilization and embryo transfer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 3040 0
Condition category
Condition code
Reproductive Health and Childbirth 3193 3193 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vaginal progesterone supplementation in early luteal phase after the treatment of in-vitro fertilization and embryo transfer (a total of nine doses of 200 mg micronized progesterone vaginally, three times daily commencing in the afternoon of oocyte retrieval till the morning of embryo transfer)
Intervention code [1] 2786 0
Treatment: Drugs
Comparator / control treatment
No vaginal pregesterone supplementation apart from the standard HCG (human chorionic gonadotrophin) luteal phase support
Control group
Active

Outcomes
Primary outcome [1] 4079 0
pregnancy rates of the treatment of in-vitro fertilization and embryo transfer
Timepoint [1] 4079 0
ten days after the last dose of HCG luteal phase support
Primary outcome [2] 4080 0
implantation rates of the treatment of in-vitro fertilization and embryo transfer
Timepoint [2] 4080 0
two weeks after positive pregnancy test of the treatment of in-vitro fertilization and embryo transfer
Secondary outcome [1] 6874 0
The difference in serum progesterone concentrations before and after the intervention (Serum progesterone level was quantified by using a competitive immunoassay with direct chemiluminesent technology)
Timepoint [1] 6874 0
on the day of ovulatory dose of HCG and the day of embryo transfer

Eligibility
Key inclusion criteria
women undergoing the treatment of in-vitro fertilization and embryo transfer, with HCG administration as the standard luteal phase support
Minimum age
20 Years
Maximum age
39 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
age = 40 year-old
use of vaginal progesterone for luteal phase support because of risk of ovarian hyperstimulation syndrome
distorted uterine cavity, e.g. due to submucosal fibroids or uterine anomalies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Informed consent was sought from potential participants on the day of ovulatory dose of HCG. The randomization was performed by computer-generated program. Sealed opaque envelopes were used for allocation. When the use of HCG administration as the standard luteal phase support had been confirmed after oocyte retrieval, the participants were randomly allocated into either the study group or the control group on one-to-one basis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization was performed by computer-generated program on one-to-one basis.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
196
Accrual to date
Final
Recruitment outside Australia
Country [1] 913 0
China
State/province [1] 913 0

Funding & Sponsors
Funding source category [1] 3291 0
University
Name [1] 3291 0
The Chinese University of Hong Kong
Country [1] 3291 0
China
Primary sponsor type
University
Name
The Chinese University of Hong Kong
Address
Department of Obstetrics & Gynaecology
Prince of Wales Hospital
The Chinese University of Hong Kong
Shatin, Hong Kong S.A.R.
Country
China
Secondary sponsor category [1] 2946 0
University
Name [1] 2946 0
The Chinese University of Hong Kong
Address [1] 2946 0
Department of Obstetrics & Gynaecology
Prince of Wales Hospital
The Chinese University of Hong Kong
Shatin, Hong Kong S.A.R.
Country [1] 2946 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5277 0
The Chinese University of Hong Kong
Ethics committee address [1] 5277 0
The Chinese University of Hong Kong
Shatin, Hong Kong S.A.R.
Ethics committee country [1] 5277 0
China
Date submitted for ethics approval [1] 5277 0
Approval date [1] 5277 0
12/12/2008
Ethics approval number [1] 5277 0
CRE-2001.381

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28522 0
Address 28522 0
Country 28522 0
Phone 28522 0
Fax 28522 0
Email 28522 0
Contact person for public queries
Name 11679 0
Po-mui LAM
Address 11679 0
Department of Obstetrics & Gynaecology
Prince of Wales Hospital
The Chinese University of Hong Kong
Shatin, Hong Kong S.A.R.
Country 11679 0
China
Phone 11679 0
852 2632 2810
Fax 11679 0
852 2636 0008
Email 11679 0
lampomui@cuhk.edu.hk
Contact person for scientific queries
Name 2607 0
Po-mui LAM
Address 2607 0
Department of Obstetrics & Gynaecology
Prince of Wales Hospital
The Chinese University of Hong Kong
Shatin, Hong Kong S.A.R.
Country 2607 0
China
Phone 2607 0
852 2632 2810
Fax 2607 0
852 2636 0008
Email 2607 0
lampomui@cuhk.edu.hk

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.