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Fertility drug trial for men with no sperm pulled before it began

NCT ID NCT03615547

Disease control Sponsor: Hospices Civils de Lyon 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 aimed to see if the drug clomiphene citrate could help men with a condition called non-obstructive azoospermia, where the body produces little to no sperm. The plan was to give the drug or a placebo for nine months, then check if sperm could be found in the semen or through a second surgical extraction. However, the trial was withdrawn before enrolling any participants, so we don't know if the drug would have helped.

What this could mean

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

Active substance
Clomiphene citrate
What this could lead to
If it had worked, this could have offered men with non-obstructive azoospermia a better chance of fathering their own biological children through a second sperm extraction procedure.
What could go wrong
The trial was withdrawn before any participants were enrolled, so no results are available. Previous studies on hormonal therapy for this condition have been small and inconsistent.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 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

18 to 55 years

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: * Patient aged from 18-55 * Body Mass Index lower than 35 * Patients with confirmed diagnostic of Non Obstructive Azoospermia based on * 2 negative spermogram with centrifugation (three month in between) * Failure of detecting spermatozoid at first testicular sperm extraction (TESE) * Patients without sperm cells at semen analysis * Signed informed consent * Patients benefiting from a social insurance system or a similar system Exclusion Criteria: * Patients with grade 2 or 3 varicocele, persistant after cure of the varicocele. * Patients with current or history of testicular tumor detected on a less than 3 months' ultrasound. * Patients with history of any other cancer of less than 5 years. * Patient with Klinefelter or karyotype abnormalities * Yq micro-deletions * First TESE conducted under hormonal treatment (Clomifene, Tamoxifen, gonadotrophins or anti-aromatase) * Patients receiving a treatment known to alter male fertility (see RCP of the treatment, colchicine, methotrexate, ….) in the 6 months before inclusion. * Patients receiving treatment know to modify the gonadotroph axis activity (FSH, TESTO, DHT, HCG…) * Hypogonadotropic Hypogonadism * Persistant bilateral abdominal cryptorchidism * Patient unable to understand the purpose of the trial or refusing to follow treatment and post-treatment instructions * Patients with history of psychiatric disorder * Participation to another trial that would interfere with this trial * Patients under legal protection

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Conditions

The condition(s) this trial relates to.

azoospermia spermatogenic failure 3 spermatogenic failure, Y-linked, 2

As listed by the trial registrant

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

Azoospermia, nonobstructive

Contacts and locations

Locations

  • Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant

    Bron, France

More trials for these conditions

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