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Efficacy of a Mediterranean diet on reproductive outcomes in couples with infertility seeking in vitro fertilisation treatment (the MEDPREP pilot study)

Efficacy of a Mediterranean diet on reproductive outcomes in couples with infertility seeking in vitro fertilisation treatment (the MEDPREP pilot study)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000936527
Enrollment
40
Registered
2024-08-01
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 wit

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.

Sponsors

Associate Professor Lisa Moran
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026