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Could a steroid fix male infertility? new trial tests prednisone

NCT ID NCT01407484

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a short course of the steroid prednisone could improve sperm quality in men with infertility caused by inflammation. Researchers measured markers of oxidative stress and sperm health six months after treatment. The trial involved 200 men and compared prednisone to a placebo.

What this could mean

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

Active substance
Prednisone (a corticosteroid anti-inflammatory drug)
What this could lead to
If it works, this could point toward a treatment for male infertility caused by inflammation, potentially improving sperm quality and fertility.
What could go wrong
This is a small, early-stage trial with only 200 participants. The treatment is short-term and may not lead to lasting improvement. Risks include side effects from steroids like weight gain or mood changes.

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

Mar 2011

Finished

May 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 years and older

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 : * Man over 18 years old * Patient presenting a leukocytospermia ≥ 0,5\*106 /ml or an elastase ≥ 500ng/ml * No infection * Signed informed consent Exclusion criteria : * Patient having less of 106 /ml of sperm cells in the ejaculate * Patients with diabetes or receiving treatment for diabetes * Patients already taking anti-inflammatory drugs * Patients with ongoing anticoagulant therapy * Patients with history of allergy to anti-inflammatory drug * Patients with a history of peptic ulcers * Patient with history of cardiovascular disease (hypertension, cardiac arrhythmia, ...) * Patients with psychological disorders * Patient with an infectious condition except for specified indications of Prednisone * Patients with some evolutional viruses(including hepatitis, herpes, chickenpox, shingles) * Patient is in a psychotic state still not controlled by treatment * Patient receiving a live vaccine * Patients with hypersensitivity to any component of Prednisone * Patient not affiliated with a social security system Criteria for randomization \- Patient meeting all inclusion criteria and none of exclusion, and having a 8OH desoxy Guanosine increased ≥ 35%.

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Conditions

The condition(s) this trial relates to.

infertility disorder leukopenia male infertility post-infectious disorder

As listed by the trial registrant

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

Leukopenia Male infertility Oxidative stress Postinfection inflammation

Contacts and locations

Locations

  • Cochin Hospital

    Paris, 75014, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.