The use of metformin in patients with polycystic ovarian syndrome requiring treatment with in vitro fertilisation (IVF)

ISRCTN	ISRCTN47219228
DOI	https://doi.org/10.1186/ISRCTN47219228
Protocol serial number	N0024120995
Sponsor	Department of Health (UK)
Funder	Homerton University Hospital NHS Trust

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 07/09/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Richard Howell
Scientific

Fertility Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom

Phone	+44 (0)20 8510 7660
Email	abc@email.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The use of metformin in patients with polycystic ovarian syndrome requiring treatment with in vitro fertilisation (IVF)
Study objectives	Metformin has been shown to be useful in patients with polycystic ovarian syndrome (PCOS) undergoing IVF. The aim of this study is to investigate whether metformin therapy in patients with polycystic ovaries can improve the fertilisation rates and significantly improve pregnancy rates.
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	Group A will be given 500 mg metformin TDS for 1 month prior to their treatment. Group B will not be treated with metformin. Both groups will undergo standard IVF treatment.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Metformin
Primary outcome measure(s)	1. Total number of folicles reaching 18 mm 2. Number of eggs obtained, number and quality of mature eggs, fertilisation rates 3. Total number of embryos, number and quality of embryos replaced and number of embryos frozen 4. Biochemical pregnancies, clinical pregnancies 5. Number of cycles abandoned for poor response and over response 6. Number of cases of ovarian hyperstimulation in each group
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	100
Key inclusion criteria	Patients with PCOS
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/2003
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Homerton University Hospital NHS Trust

London
E9 6SR
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes