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

NCT ID: NCT06831292

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-26

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Changes in SncRNA in Sperm Male Fertility RNA Profile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Diet intervention NMR

Intervention Type DIETARY_SUPPLEMENT

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

No diet intervention

No intervention - this group will only receive standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diet intervention NMR

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

23 Years

Maximum Eligible Age

56 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ostergotland County Council, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Susanne Liffner

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital

Linköping, Östergötland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Susanne Liffner, M.D, Ph.D.

Role: CONTACT

+46 (0)101030000

Facility Contacts

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Susanne Liffner, MD, PhD

Role: primary

+46101030000

Other Identifiers

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RÖ-961659 substudy 3

Identifier Type: -

Identifier Source: org_study_id

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