Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001685202
Ethics application status
Approved
Date submitted
4/10/2018
Date registered
12/10/2018
Date last updated
13/06/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot testing the usability and acceptability of an online decision aid for women considering egg freezing for non-medical reasons.
Scientific title
Pilot testing the usability and acceptability of an online decision aid for women considering egg freezing for non-medical reasons.
Secondary ID [1] 296252 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related female infertility 309912 0
Condition category
Condition code
Reproductive Health and Childbirth 308694 308694 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an online decision aid (DA), designed to assist women in making an informed decision about egg freezing for non-medical reasons (egg freezing).
The DA was developed in accordance with the International Patient Decision Aid Standards (IPDAS), and by a team of experts in fertility, psychology, women's health and decision making. Input was also provided by consumer representatives (women who had or were making a decision about egg freezing at the time of their input). The DA aims to provide women with unbiased and balanced information about egg freezing and its alternatives.
The content includes information about:
- The 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 the egg freezing procedure 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.
- Variability of outcomes between clinics (generally), and legal limits for gamete storage.
- Circumstances when 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.

The website information will be provided as text, and there are also 3 animations explaining, what impacts fertility, what egg freezing is, and what embryo freezing is. There is also a values clarification exercise to assist women to make a personalised decision.

Study participants will be given access to the website by the Research team after completing an online baseline survey. They will then be asked to review the website over a two week period before providing their feedback via a second online survey. Participants are not required to spend a minimum duration reviewing the website, it is entirely up to them. There is no monitoring of adherence during the two week review period, however participants adherence to using the website is confirmed in the follow up survey as they are asked if they had read the website. Those who answer no, are then asked to go through the website before completing the rest of the survey. The follow up survey also asks participants how much of the website they read and how long it took them.
Intervention code [1] 312583 0
Treatment: Other
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307671 0
Perceived acceptability of the DA by participants. This will be assessed using a study specific questionnaire.
Timepoint [1] 307671 0
Post-DA questionnaire which will be completed two weeks later after recruitment.
Primary outcome [2] 307764 0
Perceived worry or concern by participants resulting from of the DA. This will be assessed using a study specific questionnaire.
Timepoint [2] 307764 0
Post-DA questionnaire which will be completed two weeks after recruitment.
Primary outcome [3] 307765 0
Perceived usefulness of the DA by participants. This will be assessed using a study specific questionnaire.
Timepoint [3] 307765 0
Post-DA questionnaire which will be completed two weeks after recruitment.
Secondary outcome [1] 352532 0
Perceived improvement in participants understanding of female fertility and egg freezing (both types of questions are part of this one outcome). This will be assessed using a study specific questionnaire.
Timepoint [1] 352532 0
Post-DA questionnaire which will be completed two weeks after recruitment.
Secondary outcome [2] 352533 0
Participants decisional conflict, as measured using the validated Decisional Conflict Scale.
Timepoint [2] 352533 0
At the time of recruitment (pre-DA questionnaire), and two weeks later (post-DA questionnaire).
Secondary outcome [3] 352534 0
Participants understanding of egg freezing and female fertility, as measured using a study specific questionnaire.
Timepoint [3] 352534 0
At the time of recruitment (pre-DA questionnaire), and two weeks later (post-DA questionnaire).

Eligibility
Key inclusion criteria
- Female and aged between 18-45 years (reproductive age);
- Interested in receiving information about egg freezing;
- Live in Australia;
- Able to read English well, and;
- Have access to the internet.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who have frozen their eggs for medical reasons (i.e. before chemotherapy), or already completed their family.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/06/2018
Date of last participant enrolment
Anticipated
17/12/2018
Actual
3/01/2019
Date of last data collection
Anticipated
31/01/2019
Actual
16/01/2019
Sample size
Target
30
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 300849 0
Charities/Societies/Foundations
Name [1] 300849 0
The Royal Women's Hospital Foundation
Country [1] 300849 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne, Parkville, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 300400 0
Hospital
Name [1] 300400 0
The Royal Women's Hospital
Address [1] 300400 0
20 Flemington Rd, Parkville, VIC 3052
Country [1] 300400 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301623 0
The University of Melbourne, Medicine and Dentistry HESC
Ethics committee address [1] 301623 0
Ethics committee country [1] 301623 0
Australia
Date submitted for ethics approval [1] 301623 0
07/03/2018
Approval date [1] 301623 0
16/05/2018
Ethics approval number [1] 301623 0
1851348

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

Contacts
Principal investigator
Name 87570 0
Dr Michelle Peate
Address 87570 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 87570 0
Australia
Phone 87570 0
+61 3 8345 3792
Fax 87570 0
Email 87570 0
[email protected]
Contact person for public queries
Name 87571 0
Michelle Peate
Address 87571 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 87571 0
Australia
Phone 87571 0
+61 1800 925 330
Fax 87571 0
Email 87571 0
[email protected]
Contact person for scientific queries
Name 87572 0
Michelle Peate
Address 87572 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 87572 0
Australia
Phone 87572 0
+61 1800 925 330
Fax 87572 0
Email 87572 0
[email protected]

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.