Abstract
BACKGROUND: Add-ons at the time of in vitro fertilisation (IVF) have become commonplace, despite a general lack of evidence that they are effective and safe. The 'Colorado Protocol' is a commonly used add-on consisting of aspirin, steroid and an antibiotic. Before commencing planning for a clinical trial evaluating the Colorado Protocol, researchers and funders need evidence that the Colorado Protocol is being prescribed, and to be assured that sufficient numbers of participants can be recruited for a clinical trial. AIMS: To survey fertility clinicians and patients on attitudes toward use of add-ons during IVF, willingness of patients to be randomly assigned to an add-on trial treatment or placebo, and what would be the clinically meaningful outcomes, using the Colorado Protocol as a test case. MATERIALS AND METHODS: Two online surveys were conducted: clinicians from fertility clinics across the United Kingdom, Australia, and New Zealand; and patients from Auckland-based clinics and NZ patient support groups. RESULTS: Of 58 clinicians, 44 (75%) had recommended an add-on within the preceding year. Thirty-nine (67%) clinicians were aware of the Colorado Protocol, with 17 (29%) having recommended it within the preceding year. Of the 289 patients, 80% indicated willingness to take trial medications during IVF, and 68% were willing to be randomly assigned to the placebo arm of a trial. The median perceived minimum clinically important difference in live births in both samples was 5%. CONCLUSIONS: A future trial of this add-on in IVF would be supported by patients in the context of the New Zealand fertility healthcare system.