The Effects of Diet on Small Non-coding RNA i Sperm Cells and the Possible Effects on Reproductive Success: Diet Intervention Effects on Sperm

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age23-56
SponsorOstergotland County Council, Sweden

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male (biological) partner in infertile couple, scheduled for first IVF treatment

Mature sperm cells in semen

Able to speak and read Swedish

Omnivore

Disqualifiers

Former or present malignant disease

Former radiotherapy in pelvic area

Former chemotherapy

Known genetic/chromosomal disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diet intervention NMR

    Dietary supplement

    Participants will receive groceries to their homes with planned recipes. The recipes are planned by using the Nordic nutrition councils recommendations.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Diet intervention- Nordic nutrition recommendationsActive comparator 1 intervention
Group B: No diet interventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Sperm 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
2

Sperm total count

Sperm total count in millions, assessed by sperm analysis

Time frame
At day of ovum pick-up
3

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
4

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

Secondary outcomes

1

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
2

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
3

Embryos frozen

Number of good quality embryos frozen

Time frame
Day 5 and/or 6 after ovum pick-up
4

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

Other outcomes

1

Oxidative stress in sperm sample

Reactive oxygen species analysis of semen

Time frame
At day of ovum pick-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ostergotland County Council, Sweden

Lead sponsor

Region Östergötland

Sponsor institution