title: A randomised controlled trial of a preconceptional dietary intervention in women undergoing IVF treatment (PREPARE trial).
abstract: BACKGROUND
  In 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
  The 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  ISRCTN50956936.
authors.affiliation: Human Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton SO16 6YD, UK. Alexandra.Kermack@uhs.nhs.uk.
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Kermack
authors.forename: Philip C
authors.initials: PC
authors.lastname: Calder
authors.forename: Franchesca D
authors.initials: FD
authors.lastname: Houghton
authors.forename: Keith M
authors.initials: KM
authors.lastname: Godfrey
authors.forename: Nicholas S
authors.initials: NS
authors.lastname: Macklon
mesh_terms: D000293:Adolescent; D000328:Adult; D003296:Cooking; D004032:Diet; D019587:Dietary Supplements; D015237:Dinoprost / Q000032:analysis; D015232:Dinoprostone / Q000032:analysis; D004281:Docosahexaenoic Acids / Q000008:administration & dosage / Q000032:analysis; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage / Q000032:analysis; D047108:Embryonic Development / Q000187:drug effects*; D004717:Endometrium / Q000737:chemistry / Q000166:cytology / Q000276:immunology; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods*; D005492:Folic Acid / Q000032:analysis; D015571:Follicular Fluid / Q000737:chemistry; D006801:Humans; D008297:Male; D000069463:Olive Oil; D010938:Plant Oils / Q000008:administration & dosage; D016742:Preconception Care; D011247:Pregnancy; D018873:Pregnancy Rate; D012107:Research Design; D055101:Semen Analysis; D000074242:Sunflower Oil; D014805:Vitamin B 12 / Q000032:analysis; D025101:Vitamin B 6 / Q000032:analysis; D014807:Vitamin D / Q000008:administration & dosage / Q000032:analysis; D055815:Young Adult
chemical_list: D000069463:Olive Oil; D010938:Plant Oils; D000074242:Sunflower Oil; D014807:Vitamin D; D004281:Docosahexaenoic Acids; D025101:Vitamin B 6; D005492:Folic Acid; D015118:Eicosapentaenoic Acid; D015237:Dinoprost; D015232:Dinoprostone; D014805:Vitamin B 12