Clinical trial NCT06885151: A New Website for Australian IVF Patients: 'Evidence-based IVF'
Official title: A New Website for Australian IVF Patients 'Evidence-based IVF': an Online Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IVF
IVF Treatment
IVF-ET
IVF/ICSI
Keywords: IVF add-ons
Evidence-based IVF
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 1217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: IVF 'add-ons' are extra procedures, techniques, or medicines offered alongside standard IVF treatments, often marketed to improve success rates. Examples include EmbryoGlue, endometrial scratching, and acupuncture. However, most lack clear evidence of effectiveness or safety. Despite this, over 80% of Australian IVF patients use add-ons, sometimes paying thousands of dollars.

Patients often rely on clinic websites and online forums for information, but these sources frequently exaggerate benefits while omitting information about costs and risks. There is no independent, evidence-based resource in Australia to guide decision-making, a gap recognized by both patients and government reports.

To address this, the investigators developed "Evidence-Based IVF (EBI)," a new website informed by patient decision aid standards, expertise in digital health and risk communication, and co-design sessions with IVF patients and professionals. The investigators now plan to evaluate how well it helps patients understand the evidence base for IVF add-ons.

Detailed description: In response to widespread calls for evidence-based resources about IVF options and add-ons in Australia, the investigators assembled a multidisciplinary team to co-design a novel website prototype referred to as 'Evidence-based IVF (EBI)'. Informed by patient decision aids standards, the MAGIC App, and applying the investigators' expertise in digital and risk communication and evidence-informed health decisions, the investigators undertook interviews with Australian IVF patients and professionals to test and iteratively modify a new resource. This trial will evaluate how this website performs in terms of gist knowledge and acceptability.

Eligibility criteria: Inclusion Criteria:

* Live in Australia
* Undergone IVF/embryo transfer in the last 2 years or planning IVF/embryo transfer in the next six months. IVF refers to any IVF/ICSI/embryo transfer cycle in which the participant or their partner is planning to get pregnant.

Exclusion Criteria:

* People who underwent IVF process for egg-freezing or embryo freezing and not intending to conceive, or who received an embryo transfer as a surrogate.

Primary outcomes:
measure: Gist comprehension using bespoke 5-item questionnaire
timeFrame: 24 hours
Secondary outcomes:
measure: Proportion of participants with correct comprehension of magnitude of effect
timeFrame: 24 hours
measure: Proportion of participants with correct understanding of populations IVF add-on is applicable to
timeFrame: 24 hours
measure: Proportion of participants with correct comprehension of cost of IVF add-on
timeFrame: 24 hours
measure: Information satisfaction
timeFrame: 24 hours
measure: Emotional response
timeFrame: 24 hours
measure: Hypothetical willingness to speak to IVF specialist about using the add-on
timeFrame: 24 hours
measure: Self-assessed comprehension
timeFrame: 24 hours
measure: Information length
timeFrame: 24 hours
measure: Recommend this information
timeFrame: 24 hours
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: MDHS
state: Victoria
Study officials:
References: