A New Website for Australian IVF Patients: 'Evidence-based IVF'

Not Applicable

Completed

• Conditions: IVF; IVF Treatment; IVF-ET; IVF/ICSI

• Registration Number: NCT06885151
• Lead Sponsor: University of Melbourne

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-17
• Study Start: 2025-03-19
• Study First Posted: 2025-03-20
• Primary Completion: 2025-04-06
• Study Completion: 2025-04-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1217

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gist comprehension using bespoke 5-item questionnaire	24 hours	5-item measure, correct answer = 2 points per item, max of 10 points, higher score means better comprehension; Items 1-3. How does \[EmbryoGlue/Intralipid/ERA test\] affect the chance of \[getting pregnant/having a baby/having a miscarriage\] from IVF?; * Increases the chance; * Possibly increases the chance; * Has no effect on the chance; * Possibly decreases the chance; * Decreases the chance; * Its unclear; * I don't know; 4. The scientific studies of \[EmbryoGlue/Intralipid/ERA test\] are; * High quality and very reliable; * Moderate quality and reliable; * Low quality and somewhat reliable; * Very low quality and not at all reliable; * I don't know; 5. \[EmbryoGlue/Intralipid/ERA test\] is associated with the following risks; * Headache; * Infection; * Pain or discomfort; * Nausea and vomiting; * Fever or chills; * Hair loss; Developed from Smith 2012

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with correct comprehension of magnitude of effect	24 hours	An assessment of understanding of the magnitude of possible benefit as an absolute risk difference.; "For every 100 people having IVF, roughly how many more would \[get pregnant/have a baby/have a miscarriage\] using EmbryoGlue?; * 5 more; * 10 more; * 20 more; * The evidence is unclear; * I don't know"; (Only relevant for EmbryoGlue)
Proportion of participants with correct comprehension of cost of IVF add-on	24 hours	Expected cost of the add-on; "\[EmbryoGlue/Intralipid/ERA test\] usually costs; * Less than $500 AUD; * Between $500-$1000 AUD; * More than $1,000 AUD; * I don't know"
Information satisfaction	24 hours	How satisfied participants are with the information. Items will be combined to give a composite score out of 5 (higher score = more satisfaction).; "Please indicate below what you thought about the information for each of the below categories The information was...; * Comprehensive; * Important; * Helpful; * Trustworthy; * Balanced; * Clear and easy to understand" (each rated on 5-point scale from Strongly Disagree to Strongly Agree)
Proportion of participants with correct understanding of populations IVF add-on is applicable to	24 hours	"\[EmbryoGlue/Intralipid/ERA test\] is relevant to (tick all that apply); * Thin lining or thin endometrium; * Recurrent implantation failure; * Older female age; * Sperm or fertilization problems; * I don't know"
Emotional response	24 hours	Emotional response measured using the Berlin Emotional Responses to Risk instrument (Petrova 2023). Items will be combined to give a composite score out of 5 (higher score = better emotional response), with relevant items reverse scored.; "How did you feel when you read the information about \[EmbryoGlue/Intralipid/ERA test\]?; * Assured; * Hopeful; * Relieved; * Anxious; * Afraid; * Worried" (each measured on a 5-point scale from Strongly Disagree to Strongly Agree); Petrova D, Cokely ET, Sobkow A, Traczyk J, Garrido D, Garcia-Retamero R. Measuring feelings about choices and risks: The Berlin Emotional Responses to Risk Instrument (BERRI). Risk Anal. 2023 Apr;43(4):724-746. doi: 10.1111/risa.13946. Epub 2022 May 23. PMID: 35606164.
Hypothetical willingness to speak to IVF specialist about using the add-on	24 hours	"If I was planning another IVF cycle or embryo transfer, I would speak to my IVF specialist about using \[EmbryoGlue/Intralipid/ERA test\]" Measured on a 5 point scale from Strongly Disagree to Strongly Agree
Self-assessed comprehension	24 hours	A measure of how well participant believes they understood information provided; "After reading this information, how well do you feel you understand the potential benefits and risks of \[EmbryoGlue/Intralipid/ERA test\]?; * Not at all; * A little; * Somewhat; * Mostly; * Completely"
Information length	24 hours	Participants perspective on whether information provided was of appropriate length "How would you rate the length of information on the website?; * Much too short; * A little too short; * About right; * A little too long; * Much too long"
Recommend this information	24 hours	Whether participant would be likely to recommend the information to people considering the add-on; "Would you recommend this information to other people having IVF who are considering \[EmbryoGlue/Intralipid/ERA test\]?; * Yes; * Maybe; * No"

Trial Locations

Locations (1)

MDHS; 🇦🇺 Melbourne, Victoria, Australia