Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001136796
Ethics application status
Approved
Date submitted
9/08/2022
Date registered
17/08/2022
Date last updated
24/03/2024
Date data sharing statement initially provided
17/08/2022
Date results information initially provided
24/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of health care information on reproductive decisions
Scientific title
Women’s interest, knowledge, and attitudes relating to anti-Mullerian hormone testing: A randomised controlled trial
Secondary ID [1] 307738 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fertility testing 327314 0
Overdiagnosis 327315 0
Condition category
Condition code
Public Health 324444 324444 0 0
Health service research
Reproductive Health and Childbirth 324445 324445 0 0
Menstruation and menopause
Mental Health 324446 324446 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this trial is to test and evaluate the impact of co-designed, evidence-based information about the anti-mullerian hormone (AMH) test on women's attitudes, interest in the test, psychosocial outcomes and reproductive decision-making.

The intervention materials (evidence-based information about the AMH test) have been co-designed with a number of clinicians (IVF specialists, GPs, gynaecologists) and women (whom are the target audience of AMH test marketing).

Participants will be randomised to 1 of 2 conditions; the intervention or the control arm. The intervention arm will present women with co-designed, evidence-based information about the AMH blood test. Participants will be randomised to either the intervention or control using Qualtrics survey software. After viewing the information presented in an online, written format (soft-copy written materials with matching images), participants will complete several outcome measures. It is anticipated it will take approximately 5-10 minutes to view the intervention materials, plus a further 5-10 minutes to complete the outcome measures.

Detailed description of intervention materials: A co-designed, evidence-based information guide on the AMH blood test, concerning the nature of the test and its poor predictive value when it comes to predicting current or future fertility, as well as premature ovarian failure or age of menopause. It will also elaborate, with evidence-based information, on the following subjects: Who might benefit from an AMH-test; Risks and downsides of taking the test; costs of the test (appropriated to the country for which the guide is made); And information on preconception health and where to seek more information.

Intervention code [1] 324211 0
Behaviour
Comparator / control treatment
The control group will receive information about the AMH test that is currently available online (e.g. on direct-to-consumer websites), presented in a similar soft-copy written format (with matching images to co-designed intervention materials). This information has been found to be typically of low quality and not supported by the current evidence (e.g. claims that the test is predictive of women's current and future fertility). The layout of the control info will match the intervention, excluding the written text content.

Participants randomised to the control arm will then complete the same outcome measures. They are estimated to take a similar time to complete the study.
Control group
Active

Outcomes
Primary outcome [1] 332249 0
Interest in getting an AMH blood test.

“Now that you have read the information, are you interested in getting an AMH test?”

Measured on a 7-point scale (1=definitely not interested to 7=definitely interested)

A free text question will also ask participants to explain their choice “Please tell us why”
Timepoint [1] 332249 0
Administered immediately after participants have read the information they are randomised to (intervention or control materials).
Primary outcome [2] 332250 0
Intention to speak to doctor about the AMH test

After reading this information, would you talk to your doctor about getting an AMH test?
a. Yes
b. No
c. Don’t know
Timepoint [2] 332250 0
Immediately after participants have read the information they are randomised to (control or intervention materials)
Primary outcome [3] 332323 0
Intention to get an AMH test

Which of the following best describes your intentions to get an AMH test?
a. I definitely will get a AMH test
b. I am likely to get an AMH test
c. I am unsure
d. I am not likely to get an AMH test
e. I definitely will not get an AMH test
Timepoint [3] 332323 0
Immediately after viewing the intervention/control materials.
Secondary outcome [1] 412713 0
Attitudes about the AMH test (all measured on a 7-point scale, 1=not at all to 7=extremely, averaged to calculate a composite score with reverse scoring of relevant outcomes).
1. How beneficial does getting an AMH test seem to you?
2. How harmful does getting an AMH test seem to you? (R)
3. Do you believe that getting an AMH test will give you important information about your fertility?
4. Do you believe that getting an AMH test will give you reliable information about your fertility
Timepoint [1] 412713 0
Immediately after participants have read the information they are randomised to (control or intervention materials)
Secondary outcome [2] 412714 0
Psychosocial outcome 1

Participants will be asked to rate their level of agreement with the following statements:

1. How did you feel when you read the information about the AMH test? (all items on a 7-point scale, 1=not at all to 7=extremely). Items will be averaged to create a composite score, with relevant items reverse scored.
a. Assured
b. Hopeful
c. Relieved
d. Anxious (R)
e. Afraid (R)
f. Worried (R)

Timepoint [2] 412714 0
Immediately after participants have read the information they are randomised to (control or intervention materials)
Secondary outcome [3] 412715 0
Impact on family planning
“Do you think getting this test would influence your decision on when to start a family?” (Yes, no, not sure)
“Please explain your answer” (free text)
Timepoint [3] 412715 0
After participants have read the information they are randomised to (control or intervention materials)
Secondary outcome [4] 412716 0
Knowledge about the AMH blood test. Items will be graded as correct(1)/incorrect(0) and then summed, to give a total score out of 5.
“Please indicate whether you think the statements below about the AMH test are true or false” (True, false, don’t know)
a. The AMH level is an indication of the number of eggs in the ovaries (T)
b. The AMH level is an indication of the quality of the eggs in the ovaries (F)
c. The AMH test can reliably predict fertility (likelihood of conceiving) (F)
d. The AMH test can reliably predict age of menopause (F)
e. Oral contraception use does not affect AMH results (F)
Timepoint [4] 412716 0
After participants have read the information they are randomised to (control or intervention materials)
Secondary outcome [5] 412717 0
Medical minimiser maximiser single item scale
Thinking about how much healthcare you prefer to get: what type are you?
Sometimes, medical action is clearly necessary, and sometimes it is clearly NOT necessary. Other times, reasonable people differ in their beliefs about whether medical action is needed. In situations where it’s not clear, do you tend to lean towards taking action or do you lean towards waiting and seeing if action is needed?
Importantly, there is no “right” way to be. Please answer on the 1-6 scale below
a. I strongly lean toward waiting and seeing
b. I lean toward waiting and seeing
c. I somewhat lean toward waiting and seeing
d. I somewhat lean toward taking action
e. I lean toward taking action
f. I strongly lean toward taking action
Timepoint [5] 412717 0
After participants have read the information they are randomised to (control or intervention materials)
Secondary outcome [6] 412718 0
Confidence in knowledge
1. After reading the information presented, how confident do you feel about your knowledge about the AMH test?
a. Not at all
b. A little bit
c. Somewhat
d. Quite a bit
e. Extremely
Timepoint [6] 412718 0
After participants have read the information they are randomised to (control or intervention materials)
Secondary outcome [7] 413032 0
Information satisfaction. Items will be averaged to give a composite score out of 5 (higher score = more satisfaction).

Please indicate how you felt about the AMH information on the 5-point scale (strongly disagree to strongly agree):
The information was…
1. Comprehensive
2. Trustworthy
3. Balanced
4. Clear and easy to understand
Timepoint [7] 413032 0
After randomisation
Secondary outcome [8] 413033 0
Psychosocial outcome 2: worry about fertility

2. How worried are you about your chance of getting pregnant?
1= Not at all worried to 7= Very worried
Timepoint [8] 413033 0
with other psychosocial outcomes, after randomisation
Secondary outcome [9] 413034 0
Psychosocial outcome 3. Items will be averaged to create a composite score (higher score indicates more positive emotions), with relevant items reverse scored.

Getting an AMH test would make me feel (1=Strongly disagree to 7= strongly agree):
a. Empowered
b. Anxious (R)
c. Worried (R)
d. Reassured
e. More in control
f. Pressured, urgency to act (R)
g. Better prepared
h. Confused about what to do (R)
Timepoint [9] 413034 0
With other psychosocial outcomes, after randomisation

Eligibility
Key inclusion criteria
Nulliparous females aged 25-40 years with an active or future childbearing wish, living in Australia or The Netherlands, who have not previously had an AMH test.
Minimum age
25 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Not assigned female at birth
*No current or future childbearing wish
*Have previously given birth
*Currently pregnant
*Have previously had an AMH blood test

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)
Participants will be randomly allocated to one of the two study arms (either the co-designed information guide for the intervention group, or the control information) using Qualtrics survey software. Neither the researchers nor the market research company recruiting participants will be aware of the arm participants are randomised to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will take place through computerised sequence generation using the Randomizer function included in Qualtrics. This function utilises the Mersenne Twister pseudorandom number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will first be cleaned and checked for missing values, outliers, non-serious responders (bots, completion time less than one third of the median, nonsensical or rude responses to open ended questions). We will initially sample an additional ~20% of the required sample size to each randomised group to ensure an appropriate sample size after this process.

Baseline characteristics for both groups will be quantified, with mean and standard deviations calculated for continuous variables, as well as frequencies and relative frequencies for categorical variables. We will then use a series of regression models using SPSS Version 28.0 to test for main effects of randomised group in primary and secondary outcomes, as well as randomised condition, country, and their interaction.

Furthermore, a content analysis will serve to extract patterns and/or themes from open-ended questions and free-text responses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/08/2022
Actual
21/11/2022
Date of last participant enrolment
Anticipated
31/10/2022
Actual
19/12/2022
Date of last data collection
Anticipated
31/10/2022
Actual
19/12/2022
Sample size
Target
1000
Accrual to date
Final
967
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 24940 0
Netherlands
State/province [1] 24940 0

Funding & Sponsors
Funding source category [1] 312007 0
University
Name [1] 312007 0
The University of Sydney
Country [1] 312007 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
127A Edward Ford Building (A27), Fisher Road, Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 313504 0
None
Name [1] 313504 0
Address [1] 313504 0
Country [1] 313504 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311428 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 311428 0
Human Ethics Office
Level 3, Michael Spence Building (F23)
University of Sydney
Camperdown NSW 2006
Ethics committee country [1] 311428 0
Australia
Date submitted for ethics approval [1] 311428 0
21/01/2022
Approval date [1] 311428 0
08/04/2022
Ethics approval number [1] 311428 0
2022/177

Summary
Brief summary
The Anti-Mullerian hormone (AMH) test is currently being promoted misleadingly by online companies and fertility clinics as a fertility test for women. Importantly, research has demonstrated the test is not predictive of current or future fertility potential. It is vital women receive evidence-based information about this test free from commercial interests in order make informed decisions regarding their reproductive planning.

This study aims to co-design an evidence-based information guide with key stakeholders (clinicians and consumers) and evaluate it with two samples of women, living either in Australia or The Netherlands. The information guide will be tested using an online randomised experimental design to assess the impact of the information on women’s intention to have the test, knowledge about AMH, attitudes towards the blood test and psychosocial outcomes.

Hypothesis: It is hypothesised that women who receive the intervention (evidence-based info) will have lower interest and intention in getting an AMH test, and have higher knowledge, than women who receive the control information (misleading information currently online).

Potential significance of the current study: Given the plethora of misleading information about the AMH test online, this study will produce crucial, evidence-based information for consumers, with the goal of improving informed decision-making and reducing inappropriate test usage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121062 0
Dr Tessa Copp
Address 121062 0
Room 127A Edward Ford Building (A27)
Fisher Road, The University of Sydney
Camperdown
NSW 2006
Country 121062 0
Australia
Phone 121062 0
+61 2 86277646
Fax 121062 0
Email 121062 0
tessa.copp@sydney.edu.au
Contact person for public queries
Name 121063 0
Dr Tessa Copp
Address 121063 0
Room 127A Edward Ford Building (A27)
Fisher Road, The University of Sydney
Camperdown
NSW 2006
Country 121063 0
Australia
Phone 121063 0
+61 2 86277646
Fax 121063 0
Email 121063 0
tessa.copp@sydney.edu.au
Contact person for scientific queries
Name 121064 0
Dr Tessa Copp
Address 121064 0
Room 127A Edward Ford Building (A27)
Fisher Road, The University of Sydney
Camperdown
NSW 2006
Country 121064 0
Australia
Phone 121064 0
+61 2 86277646
Fax 121064 0
Email 121064 0
tessa.copp@sydney.edu.au

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 individual participant data collected during the trial can be made available upon request in de-identified CSV or excel datasets, along with the data dictionary
When will data be available (start and end dates)?
Data will be made freely available upon request once the manuscript outlining results from the study has been published for up to 5 years after publication
Available to whom?
Data will be made available upon request to anyone wishing to access it who provides a methodologically sound proposal to the principal investigator.
Available for what types of analyses?
Replication and meta-analysis
How or where can data be obtained?
Data can be obtained upon direct contact with the principal investigator. Contact details of the principal investigator are: tessa.copp@sydney.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16871Ethical approval    384501-(Uploaded-09-08-2022-10-47-09)-Study-related document.pdf



Results publications and other study-related documents

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