Contact information
Type
Scientific
Primary contact
Mr Richard Howell
ORCID ID
Contact details
Fertility Unit
Homerton University Hospital NHS Trust
Homerton Row
London
E9 6SR
United Kingdom
+44 (0)20 8510 7660
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0024120995
Study information
Scientific title
The use of metformin in patients with polycystic ovarian syndrome requiring treatment with in vitro fertilisation (IVF)
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Metformin
Primary outcome measures
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with PCOS
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2003
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Homerton University Hospital NHS Trust
London
E9 6SR
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
Homerton University Hospital NHS Trust
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