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

NCT06831292 | Recruiting

• 1 other identifier: RÖ-961659 substudy 3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Changes in sncRNA in Sperm; Male Fertility; RNA Profile

Keywords

male fertility; small non-coding RNA; diet; infertility; reproduction; diet intervention

Outcome Measures

Primary Outcomes (4)

• 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 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

• Sperm sample analysis

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

  At day of ovum pick-up

Secondary Outcomes (5)

• Fertilization rate

  Day one after ovum pick-up

• High quality embryo rate

  Day 6 after ovum pick-up

• Embryos frozen

  Day 5 and/or 6 after ovum pick-up

• Clinical pregnancy rate

  Assessed 5-7 weeks after ovum pick-up

• Pregnancy rate

  Assessed three weeks after ovum pick-up

Other Outcomes (1)

• Oxidative stress in sperm sample

  At day of ovum pick-up

Study Arms (2)

Diet intervention- Nordic nutrition recommendations

ACTIVE COMPARATOR

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

No diet intervention

NO INTERVENTION

No intervention - this group will only receive standard care

Interventions

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.

Diet intervention- Nordic nutrition recommendations

Eligibility Criteria

• Age: 23 Years - 56 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ostergotland County Council, Sweden: lead

Study Sites (1)

University Hospital

Linköping, Östergötland County, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Susanne Liffner, M.D, Ph.D.

CONTACT

+46 (0)101030000; susanne.liffner@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: February 18, 2025
• Study Start: December 26, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)