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Can acne drug or hormone shots help men with low sperm count?

NCT ID NCT07481370

Disease control Sponsor: University of Nebraska 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two treatments—isotretinoin (an acne medication) and hCG (a hormone)—to see if they can help men with low or no sperm count produce moving sperm. About 100 men aged 19 to 50 will take one of the drugs for three months. The goal is to find new options for male infertility when standard treatments don't work.

What this could mean

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

Active substance
isotretinoin and human chorionic gonadotropin (hCG)
What this could lead to
If successful, this could point toward a new treatment option for men with infertility due to low or absent sperm production.
What could go wrong
This is a small, early-phase study with only 100 participants. The treatments may not improve sperm production, and side effects from the medications are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Started

Apr 2026

Expected to finish

Dec 2027

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

19 to 50 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: * Male participants aged 19 to 50 years * Confirmed diagnosis of oligospermia (sperm concentration \<15 million/mL), nonobstructive azoospermia, or hypogonadotropic hypogonadism (defined by low or normal FSH with low testosterone) * Normal genetic evaluation if diagnosed with azoospermia * No other identified and correctable cause of infertility * Considered appropriate candidates for medical therapy for infertility in the clinical judgment of the investigators * Willing and able to comply with study procedures, including laboratory testing, semen analyses, and follow-up visits * Able to provide informed consent Exclusion Criteria: * Obstructive azoospermia (including vasal obstruction, ejaculatory duct obstruction, or prior vasectomy) * Prior successful medical therapy for infertility * Current or recent use of medications known to impair spermatogenesis, including exogenous testosterone or anabolic steroids, unless discontinued with adequate washout * Current use of isotretinoin for any indication * Contraindications to isotretinoin (including significant liver disease or uncontrolled hyperlipidemia) * Contraindications to human chorionic gonadotropin (including hormone-sensitive malignancy) * Significant medical or psychiatric conditions that, in the opinion of the investigators, would interfere with safe participation * Inability to provide semen samples * Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

azoospermia hypogonadotropic hypogonadism infertility disorder oligospermia 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 Infertility Oligospermia

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

More trials for these conditions

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