Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 60 Men only

Creating human sperm in a lab using testicular organoids

Official title: A Study of Therapeutic Spermatogonial Differentiation for Infertile Men Via Testicular Organoid

Run by CellARTs Inc. · NCT06841861 · Data updated 2026-11-12

This study is testing if scientists can create human sperm in a lab using special tissue samples from men to help understand and treat male infertility.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 60 Years
SexMen only
Enrollment100 (estimated)
SponsorCellARTs Inc.
Industry-sponsored
Locations1 site (San Francisco, California)
StatusRecruiting
StartedMarch 28, 2024
Main results expectedDecember 1, 2026
Study endsJanuary 1, 2027
Registry record updatedFebruary 24, 2025
Trial IDNCT06841861 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include males aged 18-60 with either evidence of fertility or a diagnosis of infertility, specifically those with azoospermia.

Probably not a fit

Patients without a diagnosis of fertility or infertility, or those lacking testicles, will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to investigate the potential for producing human sperm in vitro by maintaining a laboratory-cultured adult testicular environment. Researchers will analyze genetic factors linked to male infertility and failed sperm production by comparing genomic profiles of fertile and infertile males. The study involves constructing an 'organ-on-a-chip' model called iTestis to support the cultivation of spermatogonial stem cells and assess whether human spermatogenesis can be recreated outside the body. Participants will provide testicular and skin tissue samples for this innovative approach.

Why it matters

Potential benefit: If successful, this study could lead to new treatments for male infertility and improve sperm production in men with genetic abnormalities.

How similar studies have gone: While the approach of using organ-on-a-chip technology is innovative, similar studies exploring spermatogenesis in vitro have shown promise, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria: Group 1 (Fertile Control)

* Male sex of reproductive age (between 18 - 60 years old).
* Evidence of fertility or normal spermatogenesis.
* Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.

Inclusion Criteria: Group 2 and 3 (Infertile)

* Male sex of reproductive age (between 18 - 60 years old).
* Males with evidence of \>1 year of infertility.
* Posesses diagnosis of azoospermia is on clinical evaluation.
* Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.

Exclusion Criteria:

\- The lack of diagnosis of fertility or infertility, and lack of testicles.

Where it's running

  • The Turek Clinic
    San Francisco, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.