Changes in sncRNA in SpermDIET-ISNCT06831292
The Effects of Diet on Small Non-coding RNA i Sperm Cells and the Possible Effects on Reproductive Success: Diet Intervention Effects on Sperm
A study testing Diet intervention NMR in people with Changes in sncRNA in Sperm and Male Fertility, run by Ostergotland County Council, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 56 years, men only
- Conditions the study is for
- Changes in sncRNA in Sperm, Male Fertility, RNA Profile
- What is being tested?
- Diet intervention NMR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 26 Dec 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 56 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Former or present malignant disease
- Former radiotherapy in pelvic area
- Former chemotherapy
- Known genetic/chromosomal disorder
- Food allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
University Hospital
Linköping, Östergötland County, 58185
Susanne Liffner, MD, PhD, +46101030000, susanne.liffner@liu.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Changes in sncRNA in Sperm, Male Fertility, RNA Profile
- Being tested
- Diet intervention NMR
- Keywords
- male fertility, small non-coding RNA, diet, infertility, reproduction, diet intervention
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet intervention NMRDietary supplement
Participants will receive groceries to their homes with planned recipes. The recipes are planned by using the Nordic nutrition councils recommendations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Diet intervention NMR |
| No diet intervention | No intervention | No intervention - this group will only receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day at ovum pick-up
Sperm total count
Sperm total count in millions, assessed by sperm analysis
Measured: 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.
Measured: At day of ovum pick-up
Sperm sample analysis
Sperm motility assessed, proportion of motile sperm to total amount of sperm, reported in percent
Measured: At day of ovum pick-up
Secondary outcomes (5)
Fertilization rate
Number of normally fertilised oocytes, assessed as proportion of total number of oocytes retrieved (percent)
Measured: Day one after ovum pick-up
High quality embryo rate
Number of high quality embryo in relation to total number of oocytes fertilised
Measured: Day 6 after ovum pick-up
Embryos frozen
Number of good quality embryos frozen
Measured: 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
Measured: Assessed 5-7 weeks after ovum pick-up
Pregnancy rate
Positive pregnancy test in urine (hCG) after IVF
Measured: Assessed three weeks after ovum pick-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start26 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in sncRNA in SpermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Liffner, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831292
- Sponsor's protocol ID
- RÖ-961659 substudy 3
- Acronym
- DIET-IS
- Status last verified
- May 2026
- First submitted
- 17 Sep 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms for Male Fertility: Can Diet Change Sperm sncRNA and the Reproductive Potential?
- ClinicalTrials.gov ID
- NCT06831292
- Acronym / sponsor ID
- DIET-IS / RÖ-961659 substudy 3
- Conditions
- Changes in sncRNA in Sperm, Male Fertility, RNA Profile
- Keywords
- male fertility, small non-coding RNA, diet, infertility, reproduction, diet intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet intervention- Nordic nutrition recommendations | Active comparator | Dietary Supplement: Diet intervention NMRThe 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. |
| No diet intervention | No intervention | –No intervention - this group will only receive standard care |
Who may qualify
- Ages
- 23 to 56 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Former or present malignant disease
- Former radiotherapy in pelvic area
- Former chemotherapy
- Known genetic/chromosomal disorder
- Food allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet intervention NMRParticipants will receive groceries to their homes with planned recipes. The recipes are planned by using the Nordic nutrition councils recommendations. | Dietary supplement | Diet intervention- Nordic nutrition recommendations |
Primary outcome
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.
Sperm total count
Time frame: At day of ovum pick-up
Sperm total count in millions, assessed by sperm analysis
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.
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
5 secondary outcomes
Fertilization rate
Time frame: Day one after ovum pick-up
High quality embryo rate
Time frame: Day 6 after ovum pick-up
Embryos frozen
Time frame: Day 5 and/or 6 after ovum pick-up
Clinical pregnancy rate
Time frame: Assessed 5-7 weeks after ovum pick-up
Pregnancy rate
Time frame: Assessed three weeks after ovum pick-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet intervention NMR in people with Changes in sncRNA in Sperm and Male Fertility, run by Ostergotland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne Liffner, M.D, Ph.D. (+46 (0)101030000, susanne.liffner@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm RNA profile changes (time frame: At day at ovum pick-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.