Contact information
Type
Scientific
Primary contact
Mr AH Balen
ORCID ID
Contact details
Obstetrics & Gynaecology
C Floor
Clarendon Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 2728
adam.balen@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436118094
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Prospective randomised double-blinded placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2001
Overall trial end date
01/04/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2001
Recruitment end date
01/04/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Obstetrics & Gynaecology
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16501038
Publication citations
-
Results
Tang T, Glanville J, Orsi N, Barth JH, Balen AH, The use of metformin for women with PCOS undergoing IVF treatment., Hum. Reprod., 2006, 21, 6, 1416-1425, doi: 10.1093/humrep/del025.