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NCT Number: NCT06831292

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

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.

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Key information

Conditions

Changes in sncRNA in Sperm Genital Diseases Infertility Male Fertility RNA Profile Urogenital Diseases

Age range

23 year–56 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Linköping, Östergötland County, 58185, Sweden

Location status: Recruiting

Location contact

Susanne Liffner, MD, PhD

CONTACT

[email protected]

+46101030000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male (biological) partner in infertile couple, scheduled for first IVF treatment
  • Mature sperm cells in semen
  • Able to speak and read Swedish
  • Omnivore
  • Will refrain from nicotine and alcohol during intervention
  • Sperm sampled provided no more than 3 weeks before intervention start

Exclusion criteria

  • Former or present malignant disease
  • Former radiotherapy in pelvic area
  • Former chemotherapy
  • Known genetic/chromosomal disorder
  • Food allergy

Treatment and study plan

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.

Primary outcomes

  1. Sperm RNA profile changes

    Time frame: At day at ovum pick-up

    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.

  2. Sperm total count

    Time frame: At day of ovum pick-up

    Sperm total count in millions, assessed by sperm analysis

  3. Sperm concentration

    Time frame: At day of ovum pick-up

    Sperm concentration assessed by sperm analysis in millions/ml, with total sperm count in millions, divided by semen volume assessed in ml.

  4. Sperm sample analysis

    Time frame: At day of ovum pick-up

    Sperm motility assessed, proportion of motile sperm to total amount of sperm, reported in percent

Secondary outcomes

  1. Fertilization rate

    Time frame: Day one after ovum pick-up

    Number of normally fertilised oocytes, assessed as proportion of total number of oocytes retrieved (percent)

  2. High quality embryo rate

    Time frame: Day 6 after ovum pick-up

    Number of high quality embryo in relation to total number of oocytes fertilised

  3. Embryos frozen

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

    Number of good quality embryos frozen

  4. Clinical pregnancy rate

    Time frame: Assessed 5-7 weeks after ovum pick-up

    Defined by viable intra-uterine pregnancy at ultrasonography in gestational week 7-9

  5. Pregnancy rate

    Time frame: Assessed three weeks after ovum pick-up

    Positive pregnancy test in urine (hCG) after IVF

Other outcomes

  1. Oxidative stress in sperm sample

    Time frame: At day of ovum pick-up

    Reactive oxygen species analysis of semen

Study contacts

Contact information is provided by the study sponsor or research team.

Susanne Liffner, M.D, Ph.D.

CONTACT

[email protected]

+46 (0)101030000

Sponsors and collaborators

Lead sponsor

Ostergotland County Council, Sweden

Other

Registry information

Official study title

Molecular Mechanisms for Male Fertility: Can Diet Change Sperm sncRNA and the Reproductive Potential?

Acronym: DIET-IS

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 18, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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