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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)
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Scientific title
Efficacy of a Mediterranean diet on reproductive outcomes in couples with infertility seeking in vitro fertilisation treatment (the MEDPREP pilot study)
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Secondary ID [1]
312394
0
None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infertility
334263
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Condition category
Condition code
Reproductive Health and Childbirth
330867
330867
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0
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Fertility including in vitro fertilisation
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328944
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Lifestyle
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Day 5 embryo yield
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Assessment method [1]
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [1]
338752
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [1]
437310
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Dietary intake
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Assessment method [1]
437310
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24-hour recall (Intake24) and Mediterranean Diet Adherence Screener
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Timepoint [1]
437310
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Baseline and 8 weeks post-baseline
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Secondary outcome [2]
437311
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Physical activity levels
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Assessment method [2]
437311
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International Physical Activity Questionnaire - Short Form
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Timepoint [2]
437311
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Baseline, 8 weeks post-baseline
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Secondary outcome [3]
437312
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Severity of symptoms related to depression
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Assessment method [3]
437312
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Depression subscale of the Depression Anxiety and Stress Scale 21 (DASS-21)
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Timepoint [3]
437312
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Baseline, 8 weeks post-baseline
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Secondary outcome [4]
437313
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Acceptability of the dietary intervention
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Assessment method [4]
437313
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Online semi-structured interview and Likert scale. The interview will be conducted by a member of the research team and will last approximately 60 minutes. The interview will be audio-recorded.
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Timepoint [4]
437313
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8 weeks post-baseline
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Secondary outcome [5]
437314
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Fasting blood glucose
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Assessment method [5]
437314
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Fasting blood test
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Timepoint [5]
437314
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Baseline, 8 weeks post-baseline
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Secondary outcome [6]
437315
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Fasting blood insulin
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Assessment method [6]
437315
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Fasting blood test
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Timepoint [6]
437315
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Baseline, 8 weeks post-baseline
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Secondary outcome [7]
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Fasting blood lipids (high density lipoprotein cholesterol, low density lipoprotein cholesterol and triglycerides)
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Assessment method [7]
437316
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Fasting blood test
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Timepoint [7]
437316
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Baseline, 8 weeks post-baseline
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Secondary outcome [8]
437318
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Weight
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Assessment method [8]
437318
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Digital standing scale
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Timepoint [8]
437318
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Baseline, 8 weeks post-baseline
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Secondary outcome [9]
437324
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Oocyte yield
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Assessment method [9]
437324
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [9]
437324
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [10]
437330
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Gestational weight gain
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Assessment method [10]
437330
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Online self-report questionnaire designed specifically for this study. The questionnaire will prompt the participant to enter their weight in kilograms.
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Timepoint [10]
437330
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Start of each trimester and at 36 weeks of pregnancy, pertaining to pregnancy resulting from the in vitro fertilisation following the dietary intervention
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Secondary outcome [11]
437804
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Severity of symptoms related to anxiety
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Assessment method [11]
437804
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Anxiety subscale of Depression Anxiety and Stress Scale 21 (DASS-21)
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Timepoint [11]
437804
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Baseline, 8 weeks post-baseline
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Secondary outcome [12]
437805
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Severity of symptoms related to stress
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Assessment method [12]
437805
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Stress subscale of Depression Anxiety and Stress Scale 21 (DASS-21)
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Timepoint [12]
437805
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Baseline, 8 weeks post baseline
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Secondary outcome [13]
437806
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Feasibility of the dietary intervention
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Assessment method [13]
437806
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Online semi-structured interview and Likert scale. The interview will be conducted by a member of the research team and will last approximately 60 minutes. The interview will be audio-recorded.
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Timepoint [13]
437806
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8 weeks post-baseline
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Secondary outcome [14]
437807
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Oocyte maturity
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Assessment method [14]
437807
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [14]
437807
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [15]
437808
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Viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy)
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Assessment method [15]
437808
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [15]
437808
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [16]
437809
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Fertilisation rate
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Assessment method [16]
437809
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [16]
437809
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [17]
437810
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Pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy
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Assessment method [17]
437810
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [17]
437810
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [18]
437811
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Live birth
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Assessment method [18]
437811
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [18]
437811
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [19]
437812
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Gestational age at delivery
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Assessment method [19]
437812
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [19]
437812
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [20]
437813
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Birthweight
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Assessment method [20]
437813
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [20]
437813
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [21]
437814
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Neonatal mortality
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Assessment method [21]
437814
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [21]
437814
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [22]
437815
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Major congenital anomaly
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Assessment method [22]
437815
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [22]
437815
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [23]
437816
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Time-lapse microscopy parameters
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Assessment method [23]
437816
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [23]
437816
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [24]
437817
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Embryo utilisation rate
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Assessment method [24]
437817
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [24]
437817
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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Secondary outcome [25]
437818
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Pregnancy complications
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Assessment method [25]
437818
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These data will be collected from participants' medical records; they are routinely measured as part of the in vitro fertilisation procedure
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Timepoint [25]
437818
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Time point corresponding to the in vitro fertilisation treatment following the dietary intervention
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
316803
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Government body
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Name [1]
316803
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Australian NHMRC Funded Centre of Research Excellence Health in Preconception and Pregnancy Seed Grant
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Address [1]
316803
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Country [1]
316803
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Australia
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Funding source category [2]
316899
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Commercial sector/Industry
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Name [2]
316899
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Merck FSANZ Leaders in Innovation/ Fertility Research Grant
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Address [2]
316899
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Country [2]
316899
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Australia
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Primary sponsor type
Individual
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Name
Associate Professor Lisa Moran
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Address
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Country
Australia
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Secondary sponsor category [1]
319149
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None
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Name [1]
319149
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Address [1]
319149
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Country [1]
319149
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315573
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Melbourne IVF
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Ethics committee address [1]
315573
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http://mivf.com.au/fertility-specialists/ivf-ethics-committee
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Ethics committee country [1]
315573
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Australia
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Date submitted for ethics approval [1]
315573
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20/02/2024
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Approval date [1]
315573
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24/06/2024
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Ethics approval number [1]
315573
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Summary
Brief summary
Healthy eating is important for fertility and overall health. This study aims to compare the effects of two different healthy diets (a Mediterranean diet and the Australian Dietary Guidelines) given to couples undergoing in vitro fertilisation (IVF). Specifically, we want to understand how these two different diets affect outcomes of IVF. We also want to understand how couples undergoing IVF feel about following these diets (e.g. whether they enjoy following it, and any challenges they faced while following the diet). Currently, the Australian Dietary Guidelines are recommended for all healthy Australians as well as those with different health conditions, including pregnancy. In this study, we are comparing the effects of the Mediterranean diet, which may also help with fertility, to the Australian Dietary Guidelines. We hypothesise that a Mediterranean diet will result in a higher number of embryos produced from IVF treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Lisa Moran
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Address
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Monash Centre for Health Research and Implementation (MCHRI) 46-52 Kanooka Grove, Clayton, VIC, 3168
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Country
135118
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Australia
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Phone
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+61 385722664
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Fax
135118
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Email
135118
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[email protected]
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Contact person for public queries
Name
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Lisa Moran
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Address
135119
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Monash Centre for Health Research and Implementation (MCHRI) 46-52 Kanooka Grove, Clayton, VIC, 3168
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Country
135119
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Australia
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Phone
135119
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+61 385722664
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Fax
135119
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Email
135119
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[email protected]
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Contact person for scientific queries
Name
135120
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Lisa Moran
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Address
135120
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Monash Centre for Health Research and Implementation (MCHRI) 46-52 Kanooka Grove, Clayton, VIC, 3168
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Country
135120
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Australia
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Phone
135120
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+61 385722664
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Fax
135120
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Email
135120
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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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.
Download to PDF