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ISRCTN
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ISRCTN77388772
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ClinicalTrials.gov identifier
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Public title
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Management of anovulation associated with polycystic ovarian syndrome: a randomised trial of clomid versus clomid plus metformin.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0112128478
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Study hypothesis
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Clomid plus metamorformin is a better treatment option than Clomid alone for subfertility associated with polycystic ovarian syndrome.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nutritional, Metabolic, Endocrine: PolyCystic Ovarian Syndrome (PCOS)
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Participants - inclusion criteria
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Subfertile women attending St Helier hospital fertility clinic with problem of anovulation associated with polycystic ovarian syndrome.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/11/2003
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Anticipated end date
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31/12/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Women will be randomised in blocks of six into two groups. One group will receive Clomid plus Metformin and the second group will receive Clomid alone.
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Primary outcome measure(s)
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Pregnancy.
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Secondary outcome measure(s)
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1. Ovulation
2. Level of lutenising hormone
3. Level of testosterone
4. Body Mass Index.
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Sources of funding
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Epsom and St Helier University Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Ramasamy
Chandra
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Address
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Epsom and St. Helier NHS Trust
Women's Health
St Helier Hospital
Wrythe Lane
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City/town
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Carshalton
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Zip/Postcode
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SM5 1AA
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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09/03/2011
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Date ISRCTN assigned
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30/09/2004
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