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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Male Fertility; RNA Profile; Changes in sncRNA in Sperm
• Intervention / Treatment: Dietary supplement: Diet intervention NMR

Detailed Description

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
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susanne Liffner, M.D, Ph.D.; Phone Number: +46 (0)101030000; Email: susanne.liffner@liu.se

Study Locations

• Sweden
  • Östergötland County
    • Linköping, Östergötland County, Sweden, 58185
      • Recruiting
      • University Hospital
      • Contact: Susanne Liffner, MD, PhD; Phone Number: +46101030000; Email: susanne.liffner@liu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diet intervention- Nordic nutrition recommendations; 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.	Dietary supplement: Diet intervention NMR; Participants will receive groceries to their homes with planned recipes. The recipes are planned by using the Nordic nutrition councils recommendations.
No Intervention: No diet intervention; No intervention - this group will only receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At day at ovum pick-up
Sperm total count	Sperm total count in millions, assessed by sperm analysis	At day of ovum pick-up
Sperm sample analysis	Sperm motility assessed, proportion of motile sperm to total amount of sperm, reported in percent	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.	At day of ovum pick-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization rate	Number of normally fertilised oocytes, assessed as proportion of total number of oocytes retrieved (percent)	Day one after ovum pick-up
High quality embryo rate	Number of high quality embryo in relation to total number of oocytes fertilised	Day 6 after ovum pick-up
Embryos frozen	Number of good quality embryos frozen	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	Assessed 5-7 weeks after ovum pick-up
Pregnancy rate	Positive pregnancy test in urine (hCG) after IVF	Assessed three weeks after ovum pick-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative stress in sperm sample	Reactive oxygen species analysis of semen	At day of ovum pick-up

Collaborators and Investigators

• Sponsor: Ostergotland County Council, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: infertility; diet; diet intervention; male fertility; reproduction; small non-coding RNA
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: RÖ-961659 substudy 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No