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

NCT06885151 | Completed

• 1 other identifier: 2025-31333
• Study Type: interventional
• Target: 1,217
• Locations: 1 country
• Sites: 1

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.

Conditions

IVF; IVF Treatment; IVF-ET; IVF/ICSI

Keywords

IVF add-ons; Evidence-based IVF

Outcome Measures

Primary Outcomes (1)

• Gist comprehension using bespoke 5-item questionnaire

  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

  24 hours

Secondary Outcomes (9)

• Proportion of participants with correct comprehension of magnitude of effect

  24 hours

• Proportion of participants with correct understanding of populations IVF add-on is applicable to

  24 hours

• Proportion of participants with correct comprehension of cost of IVF add-on

  24 hours

• Information satisfaction

  24 hours

• Emotional response

  24 hours

Study Arms (2)

Evidence-based IVF information

EXPERIMENTAL

Evidence-based IVF information

Other: Evidence-based IVF website content

Control

ACTIVE COMPARATOR

Control information

Other: Control

Interventions

Evidence-based IVF website content OTHER

The Evidence-based IVF website has been developed through a robust co-design process with IVF patients and clinicians, and the information about effectiveness and safety of add-ons was produced following established systematic review methodology of Cochrane (including risk of bias, GRADE, and TRACT assessment). They will view information about one of the following IVF add-ons: Endometrial receptivity array (ERA test), EmbryoGlue, or intralipid.

Evidence-based IVF information

Control OTHER

Participants will view information that has been generated by combining information from the top 3 websites retrieved on Google search of the add-on name. They will view information about one of the following IVF add-ons: Endometrial receptivity array (ERA test), EmbryoGlue, or intralipid.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Melbourne: lead

Study Sites (1)

MDHS

Melbourne, Victoria, 3052, Australia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow, Principal Investigator

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 20, 2025
• Study Start: March 19, 2025
• Primary Completion: April 6, 2025
• Study Completion: April 6, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: January 2026 and available for 5 years
• Access Criteria: Data/information from this research project may also be used in future projects that are closely related to this project, the same general area, or could make valuable use of this data. De-identified data may be shared with other researchers upon reasonable request to Sarah Lensen.

Locations

AU (1)