Contact information
Type
Scientific
Primary contact
Dr Scott Wilkes
ORCID ID
Contact details
Department of Primary and Community care
School of Health
National and Social Sciences
Benedict Building
Sunderland
SR2 7BW
United Kingdom
+44 (0)191 5153840
scott.wilkes@sunderland.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0607138852
Study information
Scientific title
Acronym
OATS
Study hypothesis
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?
Ethics approval
Newcastle and North Tyneside NHS Local Research Ethics Committee approved on the 3rd March 2004 (ref: 2003/201)
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy and Childbirth: Fertility
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Added May 2008: The primary outcome was the time between presentation to the GP and the couple receiving a diagnosis and management plan.
Secondary outcome measures
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.
Overall trial start date
01/10/2004
Overall trial end date
30/06/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Target recruitment: 212. Actual recruitment: 670 as of May 2008.
Participant exclusion criteria
None, a pragmatic CRCT evaluating the effect of making open access HSG available to GPs for all infertile couples that present to them.
Recruitment start date
01/10/2004
Recruitment end date
30/06/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary and Community care
Sunderland
SR2 7BW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Tyneside Primary Care Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Added May 2008: Award Sponsor the NHS National Coordinating Centre for Research Capacity Development (NCCRCD) (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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19401015
Publication citations
-
Results
Wilkes S, Murdoch A, Steen N, Wilsdon J, Rubin G, Open Access Tubal aSsessment for the initial management of infertility in general practice (the OATS trial): a pragmatic cluster randomised controlled trial., Br J Gen Pract, 2009, 59, 562, 329-335, doi: 10.3399/bjgp09X420590.