Could immature sperm cells help infertile men become fathers?

NCT ID NCT04298255

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

First seen Jun 26, 2026 · Last updated Jul 29, 2026 · Updated 2 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.

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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

Contacts and locations

Locations

Carolinas Fertility Institute (CFI)
RECRUITING

Winston-Salem, North Carolina, 27103, United States

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