A randomised controlled trial of a preconceptional dietary intervention in women undergoing IVF treatment (PREPARE trial).

Alexandra J Kermack,Philip C Calder,Franchesca D Houghton,Keith M Godfrey,Nicholas S Macklon

doi:10.1186/1472-6874-14-130

Abstract

BackgroundIn vitro fertilisation (IVF) treatment provides an opportunity to study early developmental responses to periconceptional dietary interventions. Retrospective studies have suggested links between preconception diet and fertility, and more recently, a "Mediterranean" diet has been reported to increase pregnancy rates by up to 40%. In addition, a prospective study examining increased intake of omega-3 polyunsaturated fats demonstrated a quickened rate of embryo development after IVF. However, up to now, few prospective randomised controlled trials have investigated the impact of periconceptional dietary interventions on fertility outcomes.Methods and designThe study is a randomised controlled trial of a dietary intervention consisting of olive oil for cooking, an olive oil based spread, and a daily supplement drink enriched with Vitamin D (10 microgram daily) and marine omega-3 fatty acids (2 g daily) for 6 weeks preconception versus a control diet of sunflower seed oil for cooking, a sunflower oil based spread, and a daily supplement drink without added Vitamin D or marine omega-3 fatty acids. Couples undergoing IVF will be randomised to either the intervention or control group (55 in each arm). The primary endpoint is embryo developmental competency in vitro, measured by validated morphokinetic markers. Secondary outcomes will include the effect of the dietary intervention on the nutritional content of the intrauterine environment.DiscussionThis approach will enable rigorous examination of the impact of the dietary intervention on early embryo development, together with the influence of the peri-implantation intra-uterine nutritional environment.Trial registrationISRCTN50956936

Highlights

In vitro fertilisation (IVF) treatment provides an opportunity to study early developmental responses to periconceptional dietary interventions
Hypothesis Our hypothesis is that a diet rich in marine omega-3 fatty acids (FAs) and Vitamin D will be beneficial to a developing embryo and improve morphokinetic markers used to predict embryo viability and implantation
With this study we aim to clarify whether a diet rich in Vitamin D and marine omega-3 FAs significantly improves embryo development by improving morphokinetic markers of embryo quality

Summary

Introduction

In vitro fertilisation (IVF) treatment provides an opportunity to study early developmental responses to periconceptional dietary interventions. Administration of a maternal low protein diet during the 4 days of mouse pre-implantation development, followed by a control diet thereafter resulted in clear adaptive responses such as altered blastocyst numbers, upregulation of endocytosis into the yolksac, and an increase in the rate of trophoblast invasion. While these adaptive responses were observed to protect growth, they appeared to come at the cost of hypertension and abnormal behaviour patterns in adulthood [7]. Another group has shown that administering a high fat diet in this short period results in altered zygote viability [8], while treating with an insulin sensitizer during this period normalises the effects of obesity on oocyte quality and developmental competence [9]

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