IVFNCT06885151
A New Website for Australian IVF Patients: 'Evidence-based IVF'
A study testing Evidence-based IVF website content in people with IVF and IVF Treatment, run by University of Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IVF, IVF Treatment, IVF-ET
- What is being tested?
- Evidence-based IVF website content
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,217 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Mar 2025to 6 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Website for Australian IVF Patients 'Evidence-based IVF': an Online Randomised Trial
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.
Read the 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.
- Conditions
- IVF, IVF Treatment, IVF-ET, IVF/ICSI
- Being tested
- Evidence-based IVF website content, Control
- Keywords
- IVF add-ons, Evidence-based IVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based IVF website contentOther
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-based IVF information | Experimental | Evidence-based IVF information Receives: Other: Evidence-based IVF website content |
| Control | Active comparator | Control information Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
- [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
Measured: 24 hours
Secondary outcomes (9)
Proportion of participants with correct comprehension of magnitude of effect
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)
Measured: 24 hours
Proportion of participants with correct understanding of populations IVF add-on is applicable to
"[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"
Measured: 24 hours
Proportion of participants with correct comprehension of cost of IVF add-on
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"
Measured: 24 hours
Information satisfaction
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)
Measured: 24 hours
Emotional response
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.
Measured: 24 hours
Hypothetical willingness to speak to IVF specialist about using the add-on
"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
Measured: 24 hours
Self-assessed comprehension
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"
Measured: 24 hours
Information length
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"
Measured: 24 hours
Recommend this information
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"
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start19 Mar 2025
- Primary completion6 Apr 2025
- Study completion6 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Lensen, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885151
- Sponsor's protocol ID
- 2025-31333
- Other IDs
- 2025
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All survey data that does not contain personal data will be available
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Website for Australian IVF Patients 'Evidence-based IVF': an Online Randomised Trial
- ClinicalTrials.gov ID
- NCT06885151
- Acronym / sponsor ID
- 2025-31333
- Conditions
- IVF, IVF Treatment, IVF-ET, IVF/ICSI
- Keywords
- IVF add-ons, Evidence-based IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,217 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 6 Apr 2025 (actual)
- Study completion
- 6 Apr 2025 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evidence-based IVF information | Experimental | Other: Evidence-based IVF website contentEvidence-based IVF information |
| Control | Active comparator | Other: ControlControl information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence-based IVF website contentThe 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 | Evidence-based IVF information |
| ControlParticipants 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. | Other | Control |
Primary outcome
Gist comprehension using bespoke 5-item questionnaire
Time frame: 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
9 secondary outcomes
Proportion of participants with correct comprehension of magnitude of effect
Time frame: 24 hours
Proportion of participants with correct understanding of populations IVF add-on is applicable to
Time frame: 24 hours
Proportion of participants with correct comprehension of cost of IVF add-on
Time frame: 24 hours
Information satisfaction
Time frame: 24 hours
Emotional response
Time frame: 24 hours
Hypothetical willingness to speak to IVF specialist about using the add-on
Time frame: 24 hours
Self-assessed comprehension
Time frame: 24 hours
Information length
Time frame: 24 hours
Recommend this information
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: Yes. All survey data that does not contain personal data will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based IVF website content in people with IVF and IVF Treatment, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gist comprehension using bespoke 5-item questionnaire (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.