Condition category
Pregnancy and Childbirth
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
11/05/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

  1. 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.

Additional files

Editorial Notes