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
Secondary identifying numbers N0436118094
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
29/04/2010
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

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designProspective randomised double-blinded placebo-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesA 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) studiedUrological and Genital Diseases: Polycystic ovarian syndrome (PCOS)
InterventionLaboratory study; Case-note review; Database analysis; Randomised controlled trial, Random allocation to:
A. Metformin alone
B. Metformin + low dose follicle-stimulating hormone (FSH)
Intervention typeOther
Primary outcome measureChange in average oocyte retrieval rate, oocyte maturity, fertilisation rates, embryo cleavage rates, embryo quality and pregnancy rates. Change in ovarian hyperstimulation syndrome (OHSS) rates.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/10/2001
Completion date01/04/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants100
Key inclusion criteriaOur 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 criteriaNot provided at time of registration
Date of first enrolment01/10/2001
Date of final enrolment01/04/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Obstetrics & Gynaecology
Leeds
LS1 3EX
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Leeds Teaching Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2006 Yes No