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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06885151




Registration number
Help: Registration number
NCT06885151
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
5/03/2025
Date registered
Help: Date registered
20/03/2025
Date last updated
Help: Date last updated
13/06/2025

Titles & IDs
Public title
A New Website for Australian IVF Patients: 'Evidence-based IVF'
Scientific title
A New Website for Australian IVF Patients 'Evidence-based IVF': an Online Randomised Trial
Secondary ID [1] 0 0
2025-31333
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IVF 0 0
IVF Treatment 0 0
IVF-ET 0 0
IVF/ICSI 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Evidence-based IVF website content
Other interventions - Control

Experimental: Evidence-based IVF information - Evidence-based IVF information

Active comparator: Control - Control information


Other interventions: Evidence-based IVF website content
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.

Other interventions: Control
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gist comprehension using bespoke 5-item questionnaire
Timepoint [1] 0 0
24 hours
Secondary outcome [1] 0 0
Proportion of participants with correct comprehension of magnitude of effect
Timepoint [1] 0 0
24 hours
Secondary outcome [2] 0 0
Proportion of participants with correct understanding of populations IVF add-on is applicable to
Timepoint [2] 0 0
24 hours
Secondary outcome [3] 0 0
Proportion of participants with correct comprehension of cost of IVF add-on
Timepoint [3] 0 0
24 hours
Secondary outcome [4] 0 0
Information satisfaction
Timepoint [4] 0 0
24 hours
Secondary outcome [5] 0 0
Emotional response
Timepoint [5] 0 0
24 hours
Secondary outcome [6] 0 0
Hypothetical willingness to speak to IVF specialist about using the add-on
Timepoint [6] 0 0
24 hours
Secondary outcome [7] 0 0
Self-assessed comprehension
Timepoint [7] 0 0
24 hours
Secondary outcome [8] 0 0
Information length
Timepoint [8] 0 0
24 hours
Secondary outcome [9] 0 0
Recommend this information
Timepoint [9] 0 0
24 hours

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/04/2025
Sample size
Target
Accrual to date
Final
1217
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
MDHS - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Lensen, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 9035 5511
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All survey data that does not contain personal data will be available

Supporting document/s available: Study protocol, Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
January 2026 and available for 5 years
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06885151