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Sperm vacuoles may reveal hidden DNA damage

NCT ID NCT02006446

Knowledge-focused Sponsor: University Hospital, Rouen 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 200 men with sperm abnormalities to see if vacuoles (tiny holes) in the sperm head are linked to DNA damage. Researchers used high-powered microscopes and genetic tests to measure vacuole size and chromosome errors. The goal is to help doctors pick healthier sperm for fertility treatments.

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

200 people

The number who actually took part.

Started

Dec 2013

Finished

Jan 2017

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

18 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * men * 18 years old or more * affiliated to social security * with isolated teratozoospermia or oligo-astheno-teratozoospermia according to the WHO guidelines (2010): * sperm concentration \< 15 million per ml or sperm number \< 39 million per ejaculate * progressive motility \< 35% * morphologically normal forms \< 50% according to the modified David's classification (Auger et al., 2001 * mobile spermatozoa selected by density gradient centrifugation \> 1 million, in previous spermograms * with normal constitutional karyotypes (46, XY) * signed an informed consent Exclusion Criteria: * with abnormal constitutional karyotypes * with a major alteration of sperm parameters, with mobile spermatozoa selected by density gradient centrifugation \< 1 million * under tutorship or guardianship by court order

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Conditions

The condition(s) this trial relates to.

aneuploidy male infertility oligoasthenoteratozoospermia

As listed by the trial registrant

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

Male infertility

Contacts and locations

Locations

  • Laboratoire de Biologie de la Reproduction - CECOS - EA 4308, CHU - Hôpitaux de Rouen

    Rouen, 76031, France

  • Laboratoire de spermiologie, Hôpital Calmette, CHRU de Lille

    Lille, France

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