Gene and cell therapy approaches for severe male infertility (nonobstructive azoospermia)
Official title: Project III
Funded at Magee-Women's Res Inst and Foundation · NIH-11194437 · Data updated 2026-11-12
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 type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Magee-Women's Res Inst and Foundation NIH-funded |
| Lab location | 1 site (Pittsburgh, UNITED STATES) |
| Project start | September 1, 2019 |
| Project end | June 30, 2028 |
| Funding year | 2025 |
| Award (this year) | $465,881 |
| NIH project number | 5P50HD096723-07 |
| Project ID | NIH-11194437 on NIH RePORTER |
Who could benefit from this research
✓Could help
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.
✕Less likely to help
Patients with obstructive azoospermia, infertility driven primarily by female factors, or infertility unrelated to sperm-production defects are unlikely to benefit from these approaches.
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.
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 gone: 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
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Magee-Women's Res Inst and Foundation
Pittsburgh, United States Active
Researchers
- Principal investigator: Orwig, Kyle Edwin — Magee-Women's Res Inst and Foundation
- Study coordinator: Orwig, Kyle Edwin
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.