A comparison of metformin with placebo in inducing ovulation in patients with anovulatory polycystic ovary syndrome (PCOS)

ISRCTN	ISRCTN13946714
DOI	https://doi.org/10.1186/ISRCTN13946714
Protocol serial number	N0436043817
Sponsor	Department of Health (UK)
Funder	Leeds Teaching Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr AH Balen
Scientific

IVF Unit
C Floor, Clarendon Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 392 2728
Email	adam.balen@leedsth.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To compare the efficacy of metformin in the management of anovulatory women with PCOS.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Anovulatory polycystic ovary syndrome (PCOS)
Intervention	Randomised controlled trial. Random allocation to: 1. Metformin 2. Placebo
Intervention type	Other
Primary outcome measure(s)	Pregnancy/ovulation
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/2003

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key inclusion criteria	Overweight women with PCOS.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/04/1999
Date of final enrolment	01/04/2003

IVF Unit

Leeds
LS1 3EX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2006		Yes	No