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Trial registered on ANZCTR


Registration number
ACTRN12624000936527
Ethics application status
Approved
Date submitted
17/07/2024
Date registered
1/08/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
1/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a Mediterranean diet on reproductive outcomes in couples with infertility seeking in vitro fertilisation treatment (the MEDPREP pilot study)
Scientific title
Efficacy of a Mediterranean diet on reproductive outcomes in couples with infertility seeking in vitro fertilisation treatment (the MEDPREP pilot study)
Secondary ID [1] 312394 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 334263 0
Condition category
Condition code
Reproductive Health and Childbirth 330867 330867 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be allocated to an eight-week, weight-neutral, Mediterranean Diet intervention which will commence eight weeks before IVF treatment. This diet includes eating mainly plant-based foods (e.g. fruits, vegetables, herbs, spices and whole grains) as well as moderate amounts of fish, dairy and poultry, with the use of olive oil as the main source of dietary fat, and limiting the intake of red meat and added sugar. In addition, the dietary education will be in accordance with Australian preconception care guidelines (https://www1.racgp.org.au/ajgp/2018/july/preconception-care), by recommending appropriate supplementation and dietary restrictions (e.g. folic acid and iodine supplementation and avoiding alcohol for women). The dietary intervention will be administered via four fortnightly online (telehealth) dietary counselling sessions delivered by an Accredited Practising Dietitian. Each session will be approximately 30 to 60 minutes. Participants who enrol in the study as a couple will attend the dietary counselling sessions as a couple; participants who enrol in the study individually will attend the dietary counselling sessions individually. Each of the dietary counselling sessions will include dietary assessment, dietary education, individualised goal setting and meal suggestions. Dietary recommendations will be personalised according to dietary restrictions (e.g. allergies, intolerances, vegetarian), budget and preferences, and tailored to fit into existing routines. Participants will be provided with educational resources (e.g. fridge magnets and self-monitoring checklists with recommended serves of each food group). Intervention providers will use intervention manuals to promote intervention fidelity. Fidelity will be assessed using fidelity checklists.
Intervention code [1] 328944 0
Lifestyle
Comparator / control treatment
The control group will be allocated to an eight-week, weight-neutral, dietary intervention in accordance with the Australian Dietary Guidelines (https://www.eatforhealth.gov.au/sites/default/files/2022-09/n55_australian_dietary_guidelines.pdf) which will commence eight weeks before IVF treatment. This diet involves eating a wide variety of healthy foods (e.g. fruits, vegetables, dairy, lean meats, whole grains) and limiting the intake of foods high in saturated fat, salt and added sugar. In addition, the dietary education will be in accordance with Australian preconception care guidelines (https://www1.racgp.org.au/ajgp/2018/july/preconception-care), by recommending appropriate supplementation and dietary restrictions (e.g. folic acid and iodine supplementation and avoiding alcohol for women). The control dietary intervention will be administered via four fortnightly online (telehealth) dietary counselling sessions delivered by an Accredited Practising Dietitian. Each session will be approximately 30 to 60 minutes. Participants who enrol in the study as a couple will attend the dietary counselling sessions as a couple; participants who enrol in the study individually will attend the dietary counselling sessions individually. Each of the dietary counselling sessions will include dietary assessment, dietary education, individualised goal setting and meal suggestions. Dietary recommendations will be personalised according to dietary restrictions (e.g. allergies, intolerances, vegetarian), budget and preferences, and tailored to fit into existing routines. Participants will be provided with educational resources (e.g. fridge magnets and self-monitoring checklists with recommended serves of each food group). Intervention providers will use intervention manuals to promote intervention fidelity. Fidelity will be assessed using fidelity checklists.
Control group
Active

Outcomes
Primary outcome [1] 338752 0
Day 5 embryo yield
Timepoint [1] 338752 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [1] 437310 0
Dietary intake
Timepoint [1] 437310 0
Baseline and 8 weeks post-baseline
Secondary outcome [2] 437311 0
Physical activity levels
Timepoint [2] 437311 0
Baseline, 8 weeks post-baseline
Secondary outcome [3] 437312 0
Severity of symptoms related to depression
Timepoint [3] 437312 0
Baseline, 8 weeks post-baseline
Secondary outcome [4] 437313 0
Acceptability of the dietary intervention
Timepoint [4] 437313 0
8 weeks post-baseline
Secondary outcome [5] 437314 0
Fasting blood glucose
Timepoint [5] 437314 0
Baseline, 8 weeks post-baseline
Secondary outcome [6] 437315 0
Fasting blood insulin
Timepoint [6] 437315 0
Baseline, 8 weeks post-baseline
Secondary outcome [7] 437316 0
Fasting blood lipids (high density lipoprotein cholesterol, low density lipoprotein cholesterol and triglycerides)
Timepoint [7] 437316 0
Baseline, 8 weeks post-baseline
Secondary outcome [8] 437318 0
Weight
Timepoint [8] 437318 0
Baseline, 8 weeks post-baseline
Secondary outcome [9] 437324 0
Oocyte yield
Timepoint [9] 437324 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [10] 437330 0
Gestational weight gain
Timepoint [10] 437330 0
Start of each trimester and at 36 weeks of pregnancy, pertaining to pregnancy resulting from the in vitro fertilisation following the dietary intervention
Secondary outcome [11] 437804 0
Severity of symptoms related to anxiety
Timepoint [11] 437804 0
Baseline, 8 weeks post-baseline
Secondary outcome [12] 437805 0
Severity of symptoms related to stress
Timepoint [12] 437805 0
Baseline, 8 weeks post baseline
Secondary outcome [13] 437806 0
Feasibility of the dietary intervention
Timepoint [13] 437806 0
8 weeks post-baseline
Secondary outcome [14] 437807 0
Oocyte maturity
Timepoint [14] 437807 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [15] 437808 0
Viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy)
Timepoint [15] 437808 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [16] 437809 0
Fertilisation rate
Timepoint [16] 437809 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [17] 437810 0
Pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy
Timepoint [17] 437810 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [18] 437811 0
Live birth
Timepoint [18] 437811 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [19] 437812 0
Gestational age at delivery
Timepoint [19] 437812 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [20] 437813 0
Birthweight
Timepoint [20] 437813 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [21] 437814 0
Neonatal mortality
Timepoint [21] 437814 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [22] 437815 0
Major congenital anomaly
Timepoint [22] 437815 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [23] 437816 0
Time-lapse microscopy parameters
Timepoint [23] 437816 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [24] 437817 0
Embryo utilisation rate
Timepoint [24] 437817 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
Secondary outcome [25] 437818 0
Pregnancy complications
Timepoint [25] 437818 0
Time point corresponding to the in vitro fertilisation treatment following the dietary intervention

Eligibility
Key inclusion criteria
- Females scheduled for in vitro fertilisation (with or without intracytoplasmic sperm injection), with oocyte pickup following the intervention. Participation of the male partner in the dietary intervention will be strongly encouraged, but not mandatory.
- Female age 35 to 43 years. No limit for the age of the male partner.
- Use of partner sperm
- Fresh embryo transfer, or frozen to be transferred within 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Polycystic ovary syndrome
- Use of donor oocytes
- Medical contraindication to in vitro fertilisation
- Weight change of >3 kg in the 6 months prior to recruitment
- Use of frozen sperm
- More than 3 previous unsuccessful in vitro fertilisation attempts
- Preimplantation genetic testing
- Mediterranean Diet Adherence Score (MEDAS) >10 at baseline
- Not willing to be randomised to the diet

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be imported into REDCap for allocation, a secure web-based platform for building and managing online surveys and databases. The allocation will be concealed from all other researchers, as well as the clinic staff and participants through password protection and The REDCap User Rights Tool. Couples/participants will be randomly allocated via REDCap on an individual basis immediately after eligibility is confirmed by a member of the recruitment team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent biostatistician who is not involved in the study at all (outcome assessment, intervention provision or statistical analysis) will generate the randomisation sequence using Stata. The biostatistician will have access to no participant information at all.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative Data Analysis:
Statistical analysis will be performed using the intention-to-treat principle. Stata software will be used for quantitative analysis, and statistical significance will be declared if p<0.05.
For continuous outcomes with an approximately normal distribution, the summary statistics (mean and standard deviation) will be presented. Two-tailed t-tests will be used for significance testing of differences between the two intervention groups. For continuous outcomes with a non-normal distribution, the summary statistics median and interquartile range will be presented. Mann-Whitney U tests will be used for significance testing of differences between the two intervention groups. For dichotomous outcomes, frequencies and relative frequencies will be presented. Chi-square tests will be used for significance testing of differences between the two intervention groups. Risk ratio and 95% confidence intervals will be reported.

Qualitative Data Analysis:
Verbatim interview transcripts will be imported into NVivo, which will be used to support data analysis. Qualitative data will be analysed using inductive thematic analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316803 0
Government body
Name [1] 316803 0
Australian NHMRC Funded Centre of Research Excellence Health in Preconception and Pregnancy Seed Grant
Country [1] 316803 0
Australia
Funding source category [2] 316899 0
Commercial sector/Industry
Name [2] 316899 0
Merck FSANZ Leaders in Innovation/ Fertility Research Grant
Country [2] 316899 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Lisa Moran
Address
Country
Australia
Secondary sponsor category [1] 319149 0
None
Name [1] 319149 0
Address [1] 319149 0
Country [1] 319149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315573 0
Melbourne IVF
Ethics committee address [1] 315573 0
Ethics committee country [1] 315573 0
Australia
Date submitted for ethics approval [1] 315573 0
20/02/2024
Approval date [1] 315573 0
24/06/2024
Ethics approval number [1] 315573 0

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

Contacts
Principal investigator
Name 135118 0
A/Prof Lisa Moran
Address 135118 0
Monash Centre for Health Research and Implementation (MCHRI) 46-52 Kanooka Grove, Clayton, VIC, 3168
Country 135118 0
Australia
Phone 135118 0
+61 385722664
Fax 135118 0
Email 135118 0
lisa.moran@monash.edu
Contact person for public queries
Name 135119 0
Lisa Moran
Address 135119 0
Monash Centre for Health Research and Implementation (MCHRI) 46-52 Kanooka Grove, Clayton, VIC, 3168
Country 135119 0
Australia
Phone 135119 0
+61 385722664
Fax 135119 0
Email 135119 0
lisa.moran@monash.edu
Contact person for scientific queries
Name 135120 0
Lisa Moran
Address 135120 0
Monash Centre for Health Research and Implementation (MCHRI) 46-52 Kanooka Grove, Clayton, VIC, 3168
Country 135120 0
Australia
Phone 135120 0
+61 385722664
Fax 135120 0
Email 135120 0
lisa.moran@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Primary or secondary data from this project will not be made available for other researchers or secondary parties, due to ethical considerations, in order to protect the privacy and confidentiality of research participants.


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.