Open Access Tubal aSsessment for the initial management of infertility in Primary Care

ISRCTN	ISRCTN18398372
DOI	https://doi.org/10.1186/ISRCTN18398372
Secondary identifying numbers	N0607138852

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 11/05/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Scott Wilkes
Scientific

Department of Primary and Community care
School of Health
National and Social Sciences
Benedict Building
Sunderland
SR2 7BW
United Kingdom

Phone	+44 (0)191 5153840
Email	scott.wilkes@sunderland.ac.uk

Study information

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	OATS
Study objectives	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(s)	Newcastle and North Tyneside NHS Local Research Ethics Committee approved on the 3rd March 2004 (ref: 2003/201)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/2004
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Target recruitment: 212. Actual recruitment: 670 as of May 2008.
Key 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.
Key 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.
Date of first enrolment	01/10/2004
Date of final enrolment	30/06/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Primary and Community care

Sunderland
SR2 7BW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North Tyneside Primary Care Trust (UK)

No information available

Added May 2008: Award Sponsor the NHS National Coordinating Centre for Research Capacity Development (NCCRCD) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009		Yes	No