Gene and cell therapy approaches for severe male infertility (nonobstructive azoospermia)

Project III

NIH-funded research Magee-Women's Res Inst and Foundation · NIH-11194437

This project is developing gene-editing and cell-based therapies to try to restore sperm production in men with severe nonobstructive azoospermia.

Quick facts

Grant typeNIH-funded research
Study typeNIH-funded research
Funding institutionMagee-Women's Res Inst and Foundation NIH-funded
Lab location1 site (Pittsburgh, UNITED STATES)
Project IDNIH-11194437 on NIH RePORTER

What this research studies

Researchers are using mouse models that carry genetic changes linked to severe male infertility to test gene-therapy and gene-editing approaches and will perform detailed reproductive testing in those animals. They will create and edit induced pluripotent stem cells (iPSCs) from mouse models and from NOA patients, then try to turn those cells into transplantable germ cells or primordial germ cell–like cells (PGCLCs). The team will use patient-derived samples to validate targets and methods in the lab before any move toward clinical use. The work aims to link specific genetic causes of NOA to potential personalized treatment strategies.

Who could benefit from this research

Good fit: Men diagnosed with nonobstructive azoospermia (NOA), particularly those with suspected or identified genetic causes, would be the primary candidates for related future therapies or for donating samples.

Not a fit: Patients with obstructive azoospermia, infertility driven primarily by female factors, or infertility unrelated to sperm-production defects are unlikely to benefit from these approaches.

Why it matters

Potential benefit: If successful, this work could lead to personalized gene or cell therapies that restore sperm production and fertility for some men with NOA.

How similar studies have performed: Related gene-editing and iPSC-to-germ-cell approaches have shown proof-of-concept in animals and lab models but remain experimental and unproven as safe, effective therapies in people.

Where this research is happening

Pittsburgh, UNITED STATES

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-13 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.