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Could a healthier lifestyle repair sperm DNA and boost fertility?

NCT ID NCT07779954

Knowledge-focused Sponsor: Regionshospitalet Viborg, Skive Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study looks at whether damage to sperm DNA (called sperm DNA fragmentation) is common in men undergoing fertility treatment and whether it affects the chance of a live birth. About 800 men will provide semen and blood samples. Those with high sperm DNA damage (above 20%) will be randomly assigned to either a personalized 3-month lifestyle program or standard fertility care. The goal is to see if the lifestyle program can reduce sperm DNA damage and improve pregnancy outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lifestyle intervention (diet, physical activity, smoking, alcohol, sleep, stress management, and antioxidant supplements)
What this could lead to
If lifestyle changes can lower sperm DNA damage, this could point toward a simple, drug-free way to improve fertility treatment success.
What could go wrong
This is an observational study with an embedded trial, so it may only show associations, not proof. The lifestyle program is short (3 months) and may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All men of couples qualifying for either their first og second IVF or ICSI treatment Exclusion Criteria: * Insufficient sperm concentration: In samples with very low sperm counts, sperm DNA fragmentation (SDF) testing may not be technically feasible. * Surgically retrieved sperm: Men whose sperm is obtained through testicular or epididymal aspiration (TESA/PESA) will be excluded, to ensure adequate material for planned fertility procedures

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Conditions

The condition(s) this trial relates to.

male infertility

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lifestyle intervention Male infertility Sperm DNA fragmentation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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