The use of metformin in in vitro fertilisation (IVF) treatment of patients with polycystic ovary syndrome (PCOS)

ISRCTN	ISRCTN37449406
DOI	https://doi.org/10.1186/ISRCTN37449406
Protocol serial number	N0436118094
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

Obstetrics & Gynaecology
C Floor
Clarendon Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

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

Primary study design	Interventional
Study design	Prospective randomised double-blinded placebo-controlled study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	A prospective, randomised, double-blinded, placebo-controlled study using a short course of metformin treatment in patients with polycystic ovary syndrome or polycystic ovaries undergoing standard IVF treatment.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Urological and Genital Diseases: Polycystic ovarian syndrome (PCOS)
Intervention	Laboratory study; Case-note review; Database analysis; Randomised controlled trial, Random allocation to: A. Metformin alone B. Metformin + low dose follicle-stimulating hormone (FSH)
Intervention type	Other
Primary outcome measure(s)	Change in average oocyte retrieval rate, oocyte maturity, fertilisation rates, embryo cleavage rates, embryo quality and pregnancy rates. Change in ovarian hyperstimulation syndrome (OHSS) rates.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/04/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	100
Key inclusion criteria	Our unit performs about 1500 IVF cycles per year and 70% of the patients have only one cycle of treatment per year. Fifteen per cent of these patients have anovulatory infertility and almost 80% of this group of women will have PCOS. Therefore, about 125 subjects will be suitable for the trial. Assuming 75% of the subjects will participate in the trial, we should be able to recruit 100 patients per year.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2001
Date of final enrolment	01/04/2005

Obstetrics & Gynaecology

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	01/06/2006		Yes	No