Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001032943
Ethics application status
Approved
Date submitted
11/08/2020
Date registered
12/10/2020
Date last updated
22/06/2022
Date data sharing statement initially provided
12/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing different information resources on the process and quality of decision making in women considering elective egg freezing.
Scientific title
In women considering egg freezing, what is the effect of a Decision Aid plus information, compared to information alone on the process and quality of decision making.
Secondary ID [1] 302005 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related female infertility 318564 0
Health literacy 319362 0
Condition category
Condition code
Reproductive Health and Childbirth 316578 316578 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be provided with a link to the Victorian Assisted Reproductive Treatment Authority (VARTA) website and access to the online Egg Freezing decision aid (DA).

The Egg Freezing DA was developed by a working party that includes a team of experts in fertility, psychology, decision-making, women’s health as well as consumer representatives, and in accordance with the International Patient Decision Aid Standards (IPDAS). These standards are designed to enhance the quality and effectiveness of DAs. For example, by recommending that information about alternative options are sufficiently detailed, probable outcomes are unbiased and understandable, and information is presented in a structured and balanced manner. The DA aims to support the decision-making process of women considering egg freezing, by providing unbiased and evidence-based information about the process including its positive and negative aspects.

Content is delivered using informative text, animations and infographics.
Areas covered include:
• Common causes of female infertility.
• The relationship between female fertility and age.
• The benefits and uncertainties of egg freezing at different ages.
• The steps involved in egg freezing including potential risks, time commitment and costs.
• The variability and unpredictability of the number of eggs collected, and the potential need for multiple cycles to obtain goal eggs numbers.
• Personal stories from women who have considered egg freezing before.
• Variability of outcomes between clinics (generally), and legal limits for gamete storage.
• A values clarification exercise around reasons for freezing eggs.
• Circumstances in which frozen eggs might be used (including the use of donor sperm), and options of solo parenthood.
• Evidence about the outcome for children conceived using frozen eggs.
• Health, social and psychological implications of older age on pregnancy and child outcomes.

After completing the baseline survey, participants randomised to the intervention group will be emailed a link to the VARTA website and Egg Freezing DA. Participants will be told they can spend as much or as little time as they like reviewing the websites. Adherence will be monitored using website analytics and via self-report as part of the 6 and 12 month follow up surveys.
Intervention code [1] 318297 0
Behaviour
Comparator / control treatment
The control group will be provided with a link to the Victorian Assisted Reproductive Treatment Authority (VARTA) website.

VARTA is a statutory authority, funded by the Victorian Department of Health and Human Services. It provides independent information and support for individuals, couples and health professionals on fertility and issues relating to assisted reproductive treatment.

Content relating to egg freezing includes:
- Reasons for freezing;
- Steps involved;
- Storage time;
- Success rates;
- Associated potential risks;
- Financial realities, and;
- Important questions to ask a doctor.

After completing the baseline survey, participants randomised to the control group will be emailed a link to the VARTA website. Participants will be told they can spend as much or as little time as they like reviewing the website. Adherence will be monitored via self-report as part of the 6 and 12 month follow up surveys.
Control group
Active

Outcomes
Primary outcome [1] 324714 0
Participants decisional conflict as measured using the validated Decisional Conflict Scale.
Timepoint [1] 324714 0
Measured at baseline, and 6 and 12 months post randomisation.
Secondary outcome [1] 385544 0
Participants level of involvement in decision-making, as measured by the validated perceived involvement in care scale.
Timepoint [1] 385544 0
Measured at 6 and 12 months post randomisation.
Secondary outcome [2] 385545 0
Participants level of distress, as measured using the validated Depression, Anxiety and Stress Scale.
Timepoint [2] 385545 0
Measured at baseline, and 6 and 12 months post randomisation.
Secondary outcome [3] 385546 0
Length of time to make a decision, as measured by purpose designed decisional delay questions.
Timepoint [3] 385546 0
Measured at baseline, and 6 and 12 months post randomisation.
Secondary outcome [4] 385547 0
Participants knowledge about egg-freezing, as measured using a purpose designed knowledge scale.
Timepoint [4] 385547 0
Measured at baseline, and 6 and 12 months post randomisation.
Secondary outcome [5] 385548 0
Participants level of informed choice, as measured by the validated multidimensional measure of informed choice.
Timepoint [5] 385548 0
Measured at 6 and 12 months post randomisation.
Secondary outcome [6] 385549 0
Participants level of subsequent regret, as measured using the validated decisional regret scale
Timepoint [6] 385549 0
Measured at 6 and 12 months post randomisation.

Eligibility
Key inclusion criteria
1. Female and aged 18 years or over;
2. Considering egg freezing for yourself;
3. Residing in Australia for the next 12 months;
4. Sufficiently proficient in English to complete the study requirements, and;
5. Has access to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Already frozen eggs;
2. Considering egg freezing for medical reasons (i.e. before chemotherapy) or;
3. Already been through menopause.
4. Reviewed any of our previous information resources about egg freezing.

Study design
Purpose of the study
Educational / counselling / training
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/09/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
1/03/2022
Date of last data collection
Anticipated
31/12/2021
Actual
1/05/2022
Sample size
Target
286
Accrual to date
Final
306
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306426 0
Government body
Name [1] 306426 0
National Health and Medical Research Council
Country [1] 306426 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne, Parkville, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 306939 0
None
Name [1] 306939 0
Address [1] 306939 0
Country [1] 306939 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306622 0
The University of Melbourne, Medicine and Dentistry HESC
Ethics committee address [1] 306622 0
Ethics committee country [1] 306622 0
Australia
Date submitted for ethics approval [1] 306622 0
05/03/2020
Approval date [1] 306622 0
03/06/2020
Ethics approval number [1] 306622 0
2056457

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

Contacts
Principal investigator
Name 104502 0
Dr Michelle Peate
Address 104502 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 104502 0
Australia
Phone 104502 0
+61 3 8345 3792
Fax 104502 0
Email 104502 0
mpeate@unimelb.edu.au
Contact person for public queries
Name 104503 0
Sherine Sandhu
Address 104503 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 104503 0
Australia
Phone 104503 0
+61 1800 925 330
Fax 104503 0
Email 104503 0
sherines@unimelb.edu.au
Contact person for scientific queries
Name 104504 0
Michelle Peate
Address 104504 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 104504 0
Australia
Phone 104504 0
+61 3 8345 3792
Fax 104504 0
Email 104504 0
mpeate@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are no plans to share data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.