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. AIM: 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. DESIGN OF STUDY: A pragmatic cluster randomised controlled trial. SETTING: Seventy-one of 173 general practices in north-east England agreed to participate. METHOD: 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. CONCLUSION: 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.

Investigation of infertility management in primary care with open access hysterosalpingography (HSG): a pilot study.

Infertility affects one in seven couples in the United Kingdom. The National Institute for Clinical Excellence (NICE) issued guidance on the management of the infertile couple in February 2004, which included the statement "for the assessment of tubal damage, women not known to have co-morbidities (pelvic inflammatory disease, endometriosis or previous ectopic pregnancy) should be offered hysterosalpingography (HSG)". We made HSG available to six general practices in Newcastle upon Tyne as an open access investigation. Our aim was to evaluate the uptake of open access HSG, speed of access to specialist services and the quality of the information recorded in the referral letter. Using hospital clinical records we tracked the outcome of all infertile couples from the six pilot practices over a nine-month period. Of the 39 referrals identified, 10 women were eligible for open access HSG, of which six HSGs were organized by GPs. Couples who had open access HSG reached a diagnosis and management plan four weeks earlier than those who were referred directly (mean difference 4.0 weeks, 95% confidence interval (CI) -8.8 to 0.4 weeks). The information recorded in the referral letter was generally poor. However, all referrals made via the open access HSG service had the prerequisite tests done. Open access HSG allowed prompter access to specialist services with more complete information passed on in the referral letter. Open access HSG was used in 15% of all infertile couples and 60% of those who fitted the criteria for its use. Open access HSG together with semen analysis and endocrine blood tests may allow GPs to manage the initial stages of the infertile couple and make a diagnosis.