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ISRCTN
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ISRCTN18398372
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ClinicalTrials.gov identifier
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Public title
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Open Access Tubal aSsessment for the initial management of infertility in Primary Care
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Scientific title
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Acronym
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OATS
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Serial number at source
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N0607138852
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Study hypothesis
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1. Does open access HSG allow quicker access to diagnosis, prognosis management plan for the fertile couple?
2. Qualitative interviews: Patient and professional: what are the views and perceptions of both traditional and open access HSG infertility management?
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Lay summary
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Ethics approval
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Newcastle and North Tyneside NHS Local Research Ethics Committee approved on the 3rd March 2004 (ref: 2003/201)
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Study design
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Cluster 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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Pregnancy and Childbirth: Fertility
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Participants - inclusion criteria
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RCT: Approximately 106 GPs in each arm assuming 75% recruitment (info from pilot data). To measure a 30% reduction (clinically significant) in time to appropriate treatment (per Royal College of Obstetricians and Gynaecologists (RCOG) guidelines) with a 90% power and 5% significance level assuming equal numbers in each arm of the study. This is achievable with a drop out rate of 40%.
Qualitative interviews: Random simple initially then purposive sampling to prove or refute the emergent theory/themes. Interviewees will be recruited from both arms of the RCT as well as professionals involved with infertility services.
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Participants - exclusion criteria
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None, a pragmatic CRCT evaluating the effect of making open access HSG available to GPs for all infertile couples that present to them.
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Anticipated start date
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01/10/2004
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Anticipated end date
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30/06/2007
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Target recruitment: 212. Actual recruitment: 670 as of May 2008.
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Interventions
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Cluster randomised controlled trial (RCT) in Newcastle, North Tyneside & Northumberland: control practices continue to manage infertility as they are currently and intervention practices have open access HSG available.
Qualitative Interviews will describe and compare experiences of patient and professional perceptions using a grounded approach to examine the attitudes and beliefs of couples through semi-structured one to one interviews.
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Primary outcome measure(s)
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Added May 2008: The primary outcome was the time between presentation to the GP and the couple receiving a diagnosis and management plan.
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Secondary outcome measure(s)
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Added May 2008: Secondary outcomes were the uptake of open access HSG, frequency of diagnoses, first-line treatments offered, pregnancy rates and a measure of the extent of the information recorded and/or passed on in the referral letters of those subsequently referred.
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Sources of funding
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1. North Tyneside Primary Care Trust (UK)
2. Added May 2008: Award Sponsor the NHS National Coordinating Centre for Research Capacity Development (NCCRCD) (UK)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19401015
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Contact name
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Dr
Scott
Wilkes
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Address
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Department of Primary and Community care
School of Health
National and Social Sciences
Benedict Building
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City/town
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Sunderland
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Zip/Postcode
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SR2 7BW
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Country
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United Kingdom
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Tel
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+44 (0)191 5153840
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Email
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scott.wilkes@sunderland.ac.uk
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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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11/05/2009
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Date ISRCTN assigned
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30/09/2004
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