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Sperm DNA damage may play role in unexplained miscarriages

NCT ID NCT02572154

Knowledge-focused Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether sperm DNA damage is linked to early recurrent pregnancy loss in couples where standard tests found no cause. Researchers compared sperm samples from men in couples with unexplained recurrent pregnancy loss to those from men who had a healthy pregnancy. The goal was to see if higher sperm DNA fragmentation is more common in the miscarriage group.

What this could mean

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

What this could lead to
If this study finds a link, it could point toward new ways to evaluate male fertility in couples with recurrent pregnancy loss.
What could go wrong
This is a small, completed observational study, not a treatment trial. It may not prove cause and effect, and results may not apply to all couples.

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

64 people

The number who actually took part.

Start date

Sep 2012

Finished

Jul 2015

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 to 55 years

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: * Cases: Man from couples with RPL (more than 2 miscarriages) RPL classical etiological exploration negative (unexplained RPL) Healthy voluntaries * Control: Man from couples who have a child after a natural pregnancy obtained in the year following child desire. Healthy voluntaries Exclusion Criteria: * Cases: Etiological exploration of RPL positive Man with chromosomal anomaly * Cases and controls: Ongoing pathology Chemotherapy or radiotherapy history Hyperthermia (fever) in the last three months Pregnancy obtained by assisted reproduction (Inseminations, in vitro fertilization) Women \> 38 year old

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Conditions

The condition(s) this trial relates to.

habitual spontaneous abortion pregnancy loss, recurrent, 4 pregnancy loss, recurrent, susceptibility

As listed by the trial registrant

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

Recurrent pregnancy loss

Contacts and locations

Locations

  • APHM

    Marseille, France

  • Chu Bordeaux

    Bordeaux, France

  • Chu Toulouse

    Toulouse, France

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