Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000027718
Ethics application status
Approved
Date submitted
21/12/2012
Date registered
10/01/2013
Date last updated
10/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Live birth rate after metformin and clomiphene vs clomiphene alone in polycystic ovary syndrome (PCOS): a randomized, double-blind, placebo-controlled trial.
Scientific title
Live birth rate after metformin and clomiphene vs clomiphene alone in polycystic ovary syndrome (PCOS): a randomized, double-blind, placebo-controlled trial.
Secondary ID [1] 281607 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polycystic ovary syndrome 287889 0
subfertility 287890 0
Condition category
Condition code
Reproductive Health and Childbirth 288268 288268 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
standard preparation metformin, 500mg, orally, three times per day (TDS) and clomiphene citrate 25mg-150mg (dose determined by treating clinician), orally, daily. Clomiphene citrate was administered from day 3-7 of the menstrual cycle. Metformin was administered daily continuously or until pregnancy was confirmed via a beta-hcg.
Intervention code [1] 286142 0
Treatment: Drugs
Comparator / control treatment
placebo tablet (identical to metformin but without the active ingredient), orally, three times per day (TDS) and clomiphene citrate 25mg-150mg (dose determined by treating clinician), orally, daily. Clomiphene citrate was administered from day 3-7 of the menstrual cycle. The Placebo was administered daily continuously or until pregnancy was confirmed via a beta-hcg.
Control group
Placebo

Outcomes
Primary outcome [1] 288444 0
ovulation
Timepoint [1] 288444 0
Ovulation was defined by a serum progesterone measurement > 10.6 nmol/l on either day 21-23 or day 28-30 of the participants menstrual cycle
Secondary outcome [1] 300173 0
chemical pregnancy
Timepoint [1] 300173 0
Chemical pregnancy was defined as Beta-hCG > 5 IU/l between days 28-30 or in the case of late ovulation (luteal phase progesterone between days 28-30) between days 35-37 of the participants menstrual cycle
Secondary outcome [2] 300174 0
live birth documented in the patients medical records by a medical practitioner
Timepoint [2] 300174 0
once chemical pregnancy was confirmed participants were followed up throughout the course of the trial
Secondary outcome [3] 300175 0
miscarriage confirmed by a doctor resulting in a beta-hcg <5IU/L
Timepoint [3] 300175 0
once chemical pregnancy was confirmed participants were followed up throughout the course of the trial

Eligibility
Key inclusion criteria
women with polycystic ovary syndrome, desiring pregnancy, with subfertility
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women were excluded from the study if they had other causes of anovulation (specifically hyperprolactinaemia, hypothyroidism and congenital adrenal hyperplasia), diabetes mellitus or if the semen analysis of their partner indicated male factor subfertility

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)
participants were recruited from the Royal Brisbane and Women's Hospital Gynaecology outpatient department. Allocation was double blinded and executed by the hospital pharmacy department.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/12/1998
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 6069 0
4029

Funding & Sponsors
Funding source category [1] 286416 0
University
Name [1] 286416 0
University of Queensland
Country [1] 286416 0
Australia
Primary sponsor type
Individual
Name
Dr Clare Boothroyd
Address
Suite 9a, Administrative Building
Greenslopes Private Hospital
Newdegate street
Greenslopes
QLD, 4120
Country
Australia
Secondary sponsor category [1] 285200 0
Individual
Name [1] 285200 0
Dr Georgia Heathcote
Address [1] 285200 0
3/396 Scarborough Road,
Scarborough
QLD, 4020
Country [1] 285200 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The study was approved in 1998 by the Royal Brisbane Human Research Ethics Committee.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35003 0
Dr Clare Boothroyd
Address 35003 0
Suite 25, level 1
Greenslopes Specialist Centre
Newdegate Street,
Greenslopes
Brisbane
QLD, 4120
Country 35003 0
Australia
Phone 35003 0
+61 07 3394 4108
Fax 35003 0
Email 35003 0
[email protected]
Contact person for public queries
Name 18250 0
Dr Georgia Heathcote
Address 18250 0
3/396 Scarborough Road,
Scarborough
QLD, 4020
Country 18250 0
Australia
Phone 18250 0
+61 0447577910
Fax 18250 0
Email 18250 0
[email protected]
Contact person for scientific queries
Name 9178 0
Dr Georgia Heathcote
Address 9178 0
3/396 Scarborough Road,
Scarborough
QLD, 4020
Country 9178 0
Australia
Phone 9178 0
+61 0447577910
Fax 9178 0
Email 9178 0
[email protected]

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.