Open Access Tubal aSsessment for the initial management of infertility in general practice (the OATS trial): a pragmatic cluster randomised controlled trial.
BACKGROUND
GPs investigate approximately half of all infertile couples with semen analysis and endocrine blood tests. For assessment of tubal status, hysterosalpingography (HSG) is recommended as a first-line investigation for women not known to have comorbidities.


OBJECTIVE
To test whether providing GPs with open access to HSG results in infertile couples progressing to a diagnosis and management plan sooner than with usual management.


METHODS
A pragmatic cluster randomised controlled trial.


METHODS
Seventy-one of 173 general practices in north-east England agreed to participate.


METHODS
A total of 670 infertile couples presented to 33 intervention practices and 25 control practices over a 2-year period. Practices allocated to the intervention group had access to HSG for those infertile women who fulfilled predefined eligibility criteria. The primary outcome measure was the interval between presentation to the GP and the couple receiving a diagnosis and management plan.


RESULTS
An annual incidence of 0.8 couples per 1000 total population equated to each GP seeing an average of one or two infertile couples each year. Open access HSG was used for 9% of all infertile women who presented to the intervention practices during the study period. The time to reach a diagnosis and management plan for all infertile couples presenting was not affected by the availability of open access HSG (Cox regression hazard ratio = 0.9, 95% confidence interval [CI] = 0.7 to 1.1). For couples who reached a diagnosis and management plan, there was a non-significant difference in time to primary outcome for intervention versus control practices (32.5 weeks versus 30.5 weeks, mean difference 2.2 weeks, 95% CI = 1.6 to 6.1 weeks, P = 0.1). The intracluster correlation coefficient was 0.03 across all practices.


CONCLUSIONS
Providing GPs with open access to HSG had no effect on the time taken to reach a diagnosis and management plan for couples with infertility.
Wilkes
Scott
S
Centre for Primary and Community Care, School of Health Natural and Social Sciences, University of Sunderland, Sunderland.
Murdoch
Alison
A
Steen
Nick
N
Wilsdon
John
J
Rubin
Greg
G
D000293:Adolescent; D000328:Adult; D005194:Family Practice; D005260:Female; D006297:Health Services Accessibility / Q000458:organization & administration*; D006801:Humans; D007047:Hysterosalpingography; D007247:Infertility, Female / Q000000981:diagnostic imaging* / Q000209:etiology / Q000628:therapy; D008297:Male; D011364:Professional Practice; D012017:Referral and Consultation; D013997:Time Factors; D055815:Young Adult