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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18398372
Enrollment
212
Registered
2004-09-30
Start date
2004-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth: Fertility Pregnancy and Childbirth Fertility

Interventions

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 acc

Sponsors

Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Added May 2008: The primary outcome was the time between presentation to the GP and the couple receiving a diagnosis and management plan.

Secondary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026