In this study, patients with infertility treated with IVF at the Center of Reproductive Medicine in Linköping, Sweden, will receive recipes and food according to Nordic dietary guidelines. The purpose is to investigate whether a short diet intervention is sufficient to improve sperm quality and shift the small non-coding RNA profile. In our previous study sperm showed rapid response to diet.
This study is a randomized controlled trial recruiting males seeking IVF treatment with their female partner at the Center for Reproductive Medicine in Linkoping, Sweden. Men will be randomized to a control group or diet intervention group. The intervention group will receive groceries with planned recipes during the hormonal treatment period for the woman (11-14 days) before IVF. The meal plan will be according to the Nordic dietary guidelines and individualized to match total energy expenditure. The male partner must accept to participate in the diet intervention in order to be included and the female partner can choose to participate in the diet intervention but it is optional. Sperm samples will be collected before the start of hormonal treatment and on ovum pick-up day. Weight will be measured before and after the intervention. Sperm samples will be processed as standard practice at the fertility clinic. Sperm samples will be used for molecular analysis, such as small RNA sequencing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
100
Participants will receive groceries to their homes with planned recipes. The recipes are planned by using the Nordic nutrition councils recommendations.
University Hospital
Linköping, Östergötland County, Sweden
RECRUITINGSperm RNA profile changes
Small RNA profiling and sequencing will be performed on sperm cells provided by participant at the start of controlled ovarian hormone stimulation of partner and at time of ovum pick-up and compared between the intervention groups.
Time frame: At day at ovum pick-up
Sperm total count
Sperm total count in millions, assessed by sperm analysis
Time frame: At day of ovum pick-up
Sperm concentration
Sperm concentration assessed by sperm analysis in millions/ml, with total sperm count in millions, divided by semen volume assessed in ml.
Time frame: At day of ovum pick-up
Sperm sample analysis
Sperm motility assessed, proportion of motile sperm to total amount of sperm, reported in percent
Time frame: At day of ovum pick-up
Fertilization rate
Number of normally fertilised oocytes, assessed as proportion of total number of oocytes retrieved (percent)
Time frame: Day one after ovum pick-up
High quality embryo rate
Number of high quality embryo in relation to total number of oocytes fertilised
Time frame: Day 6 after ovum pick-up
Embryos frozen
Number of good quality embryos frozen
Time frame: Day 5 and/or 6 after ovum pick-up
Clinical pregnancy rate
Defined by viable intra-uterine pregnancy at ultrasonography in gestational week 7-9
Time frame: Assessed 5-7 weeks after ovum pick-up
Pregnancy rate
Positive pregnancy test in urine (hCG) after IVF
Time frame: Assessed three weeks after ovum pick-up
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