Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001728224
Ethics application status
Approved
Date submitted
4/10/2018
Date registered
19/10/2018
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring the information and decision making needs of women considering egg freezing for non-medical reasons.
Scientific title
Exploring the information and decision making needs of women considering egg freezing for non-medical reasons.
Secondary ID [1] 294729 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related female infertility 307611 0
Condition category
Condition code
Reproductive Health and Childbirth 306667 306667 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Conceiving before fertility naturally declines may be unsuitable or impossible for some women. Egg freezing for non-medical reasons can extend a woman's reproductive lifespan, and minimise the risk of age-related infertility. However, the decision to freeze is complex and requires multiple considerations including the uncertainty of outcomes, age, health, financial and psychological factors.

This study will observe women who have an interest in egg freezing information, as our aim is to understand what they need in terms of information and decision making support. Some of these women may have already made a decision about egg freezing, whilst others may have not. All participants will be asked to complete the same 10-15 minute one-off survey.



Intervention code [1] 312572 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307651 0
Participant's decisional conflict and uncertainty, as measured using the validated Decisional Conflict Scale.
Timepoint [1] 307651 0
At time of survey.
Primary outcome [2] 307816 0
Participant's understanding of egg freezing and female fertility, as measured using a study specific questionnaire.
Timepoint [2] 307816 0
At time of survey.
Primary outcome [3] 307817 0
Participant's perceptions of information needs and preferred method of delivery, as measured using a study specific questionnaire. This is a composite outcome which measures the importance of being properly informed about egg freezing, the age participants think women should be informed about egg freezing, and also who participants think should provide egg freezing information.
Timepoint [3] 307817 0
At time of survey.
Secondary outcome [1] 352500 0
Participants length of time considering egg freezing, as measured by a study specific questionnaire.
Timepoint [1] 352500 0
At time of survey.
Secondary outcome [2] 353035 0
Participants demographics, as measured by a study specific questionnaire. This includes questions asking current age, relationship status, postcode, country of birth, time lived in Australia, Aboriginal or Torres Strait Islander origin, first language spoken at home, highest level of education, medical and allied health training, employment status, profession, parity and desire for children.
Timepoint [2] 353035 0
At time of survey.
Secondary outcome [3] 353036 0
Participants preferences for egg freezing information communication methods, as measured by a study specific questionnaire. These methods include: brief pamphlet, paper copy decision aid, written booklet (not a decision aid), online interactive decision aid, DVD for patients to take home, communication aid for consultation (such as flip chart), website with accurate information, and website which calculates personalised fertility.
Timepoint [3] 353036 0
At time of survey.
Secondary outcome [4] 353037 0
Participants preferences for non-medical egg freezing terminology, as measured by a study specific questionnaire. These terms include: social egg freezing, egg freezing for non-medical reasons, eggsurance, oocyte cryopreservation for anticipated gamete exhaustion, egg freezing for circumstantial infertility, non-medical fertility preservation, age-related egg freezing, non-medical egg banking.
Timepoint [4] 353037 0
At time of survey.
Secondary outcome [5] 353038 0
Participants methods of sourcing of information, as measured by a study specific questionnaire. This is a composite outcome which includes questions asking if they talk to their friends about egg freezing, if they have consulted a fertility specialist, how they have researched egg freezing, and how long ago they started looking for egg freezing information.
Timepoint [5] 353038 0
At time of survey.

Eligibility
Key inclusion criteria
Women who are:
- Currently aged between 18-45 years;
- Interested in receiving egg freezing information;
- 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:
- Already completed their family, or;
- Frozen their eggs for medical reasons (e.g. prior to chemotherapy).

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
The target sample size is 120 women to allow for adequate conclusions to be drawn. Basic descriptive statistics will be calculated using SPSS to analyse survey responses.
Qualitative thematic analysis will also be performed on the commentary provided in the free text fields of the survey. This will be done by identifying key words, concepts and reflections in accordance with the Miles & Huberman framework for qualitative research methodology, and also using NVivo,

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/06/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
31/12/2018
Date of last data collection
Anticipated
31/12/2018
Actual
31/12/2018
Sample size
Target
120
Accrual to date
Final
358
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299337 0
University
Name [1] 299337 0
The University of Melbourne
Country [1] 299337 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] 298604 0
Hospital
Name [1] 298604 0
The Royal Women's Hospital
Address [1] 298604 0
20 Flemington Rd, Parkville, VIC 3052
Country [1] 298604 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300244 0
The University of Melbourne, Medicine and Dentistry HESC
Ethics committee address [1] 300244 0
Ethics committee country [1] 300244 0
Australia
Date submitted for ethics approval [1] 300244 0
07/03/2018
Approval date [1] 300244 0
16/05/2018
Ethics approval number [1] 300244 0
1851348

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

Contacts
Principal investigator
Name 83026 0
Dr Michelle Peate
Address 83026 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 83026 0
Australia
Phone 83026 0
+61 3 8345 3792
Fax 83026 0
Email 83026 0
[email protected]
Contact person for public queries
Name 83027 0
Michelle Peate
Address 83027 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 83027 0
Australia
Phone 83027 0
+61 1800 925 330
Fax 83027 0
Email 83027 0
[email protected]
Contact person for scientific queries
Name 83028 0
Michelle Peate
Address 83028 0
Department of Obstetrics & Gynaecology, University of Melbourne, Level 7, Royal Women's Hospital, Cnr Grattan Street & Flemington Road, Parkville, VIC 3052
Country 83028 0
Australia
Phone 83028 0
+61 1800 925 330
Fax 83028 0
Email 83028 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
This has not been planned.


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.