Open Access Tubal aSsessment for the initial management of infertility in Primary Care
| ISRCTN | ISRCTN18398372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18398372 |
| Protocol serial number | N0607138852 |
| Sponsor | Department of Health |
| Funders | North Tyneside Primary Care Trust (UK), Added May 2008: Award Sponsor the NHS National Coordinating Centre for Research Capacity Development (NCCRCD) (UK) |
- 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
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 |
|---|---|
| scott.wilkes@sunderland.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Added May 2008: The primary outcome was the time between presentation to the GP and the couple receiving a diagnosis and management plan. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 212 |
| 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
- United Kingdom
- England
Study participating centre
Department of Primary and Community care
Sunderland
SR2 7BW
United Kingdom
SR2 7BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
