Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000510246
Ethics application status
Approved
Date submitted
17/06/2009
Date registered
29/06/2009
Date last updated
29/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, randomised, open label trial on the effect of metformin on in-vitro fertilisation outcome in women with polycystic ovary syndrome
Scientific title
A prospective, randomised, open label trial on the effect of metformin on livebirth rates in women with polycystic ovary syndrome undergoing in-vitro fertilization
Secondary ID [1] 887 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 4882 0
Polycystic ovary syndrome 237080 0
Condition category
Condition code
Reproductive Health and Childbirth 237234 237234 0 0
Fertility including in vitro fertilisation
Metabolic and Endocrine 237374 237374 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metformin with ovarian stimulation to be continued to 12 weeks gestation if pregnant.
500mg per day metformin slow release (xr) oral tablet for 1 week
1000mg of metformin xr for 1 week
1500mg metformin xr for the remainder of the trial. Metformin to be ceased with negative pregnancy test, or the end of the 12th week of pregnancy
Ovarian stimulation involves subcuticular injections of follicle stimulating hormones and a gonadotrophin releasing hormone(GnRH) antagonist as per the IVF Australia Antagonist:superovulation protocol. There are 2 different dose regimes for GnRH and this depends on the doctor. An injection of 250 international units of human chorionic gonadotrophin is given 36 hours prior to egg collection
Intervention code [1] 236669 0
Treatment: Drugs
Comparator / control treatment
Women with the same condition undergoing an antagonist cycle of in-vitro fertilisation(IVF) who have been randomised to no treatment as opposed to treatment with metformin, ie. no metformin with standard in-virto fertilisation(IVF) treatment.
Control group
Active

Outcomes
Primary outcome [1] 238179 0
Livebirth
Timepoint [1] 238179 0
10 months after randomisation
Secondary outcome [1] 242478 0
Miscarriage rate
Timepoint [1] 242478 0
16 weeks after randomization

Eligibility
Key inclusion criteria
Polycystic ovary syndrome(PCOS)
Infertility
Both ovaries present
Informed Consent to in-vitro fertilisation treatment
Age 20-38years inclusive
Use of an Antagonist cycle
Minimum age
20 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to metformin
Metformin use in previous month
Previous participation in the trial
Oocyte donor

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)
The patient is enrolled and then randomised via a central randomisation website
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random computer generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237138 0
Charities/Societies/Foundations
Name [1] 237138 0
Fertility Society of Australia
Country [1] 237138 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Fertility Society of Australia
Address
61 Dank St
Port Melbourne
VIC 3207
Country
Australia
Secondary sponsor category [1] 4691 0
None
Name [1] 4691 0
Address [1] 4691 0
Country [1] 4691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239231 0
IVF Australia Ethics Committee
Ethics committee address [1] 239231 0
Ethics committee country [1] 239231 0
Australia
Date submitted for ethics approval [1] 239231 0
Approval date [1] 239231 0
01/05/2009
Ethics approval number [1] 239231 0

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

Contacts
Principal investigator
Name 29669 0
Address 29669 0
Country 29669 0
Phone 29669 0
Fax 29669 0
Email 29669 0
Contact person for public queries
Name 12916 0
Juliette Koch
Address 12916 0
Reproductive Medicine
Royal Hospital for Women
Barker St
Randwick 2031
NSW
Country 12916 0
Australia
Phone 12916 0
+61 2 93826666
Fax 12916 0
Email 12916 0
juliette.koch@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 3844 0
Juliette Koch
Address 3844 0
Reproductive Medicine
Royal Hospital for Women
Barker St
Randwick
NSW 2031
Country 3844 0
Australia
Phone 3844 0
+61 2 93826666
Fax 3844 0
Email 3844 0
juliette.koch@sesiahs.health.nsw.gov.au

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.