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Could immature sperm cells help infertile men become fathers?

NCT ID NCT04298255

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This study tests whether round spermatids (immature sperm cells) can be used in IVF to help men with a condition called non-obstructive azoospermia, where no mature sperm are present. Researchers will collect these cells from the testicles and inject them into eggs to see if they can create embryos. The study involves 50 couples and compares results using only the man's cells versus using donor sperm as a backup.

What this could mean

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

Active substance
Round Spermatid Injection (ROSI) procedure
What this could lead to
If successful, this could offer a new way for men with no sperm in their ejaculate to father biological children using their own cells.
What could go wrong
This is an early, small study (50 couples) testing a new technique. It may not lead to successful pregnancies, and there are unknown risks to embryos.

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

About 50 people

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

Started

Aug 2020

Expected to finish

Jul 2028

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 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: * Males with no elongated spermatids or spermatozoa present but with round spermatids present on TESE (Testicular Sperm Extraction) * Male diagnosed with non-obstructive Azoospermia * Male partner ≥18 * Female partner greater than 18 years of age and less than 38 years of age or Anti Mullerian Hormone (AMH) greater than 2 ng/ml. Exclusion Criteria: * Males with obstructive azoospermia * Males with presence an adequate number of elongated spermatids or spermatozoa

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Conditions

The condition(s) this trial relates to.

azoospermia male infertility

As listed by the trial registrant

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

Infertility, male

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Carolinas Fertility Institute (CFI)

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

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