How strong is the evidence for stem-cell therapy in Male Infertility?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is thin and mostly exploratory: the registry holds 15 records, 5 completed, 0 at Phase 3 or 4, and 1 stopped early (7%). MSC-specific work accounts for 4 of those records. These counts describe research activity and maturity, not benefit, safety or certainty. Snapshot 2026-08-29.
What counts as a real result in Male Infertility
The only endpoints worth quoting are sperm retrieval rate, clinical pregnancy and live birth, reported per cycle with the concurrent IVF protocol described. Hormone-level changes are not fertility.
What we can say from registrations alone
- Volume: 15 registered studies since 2009.
- Maturity: 0 confirmatory-phase records.
- Delivery: 5 completed; 1 terminated, withdrawn or suspended.
- Scale: median planned enrolment 60 participants, largest 600.
The completed studies
Completed does not mean published, and published does not mean positive. These are the finished records — the starting point for checking whether results ever appeared.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT02756923 — Regulation of Stem Spermatogonia in the Mature Testis | n/a | Completed | 142 | Weill Medical College of Cornell University | 2012-04 |
| NCT02025270 — MSCs For Treatment of Azoospermic Patients | Phase 1, Phase 2 | Completed | 100 | Al-Azhar University | 2012-10-15 |
| NCT02380755 — Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism | Phase 2 | Completed | 78 | University of Sao Paulo | 2015-04 |
| NCT01375062 — Obtaining Undifferentiated Cells From Testis Biopsy | n/a | Completed | 65 | Igenomix | 2009-05 |
| NCT02414295 — Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection | n/a | Completed | 1 | Man Clinic for Andrology, Male Infertility and Sexual Dysfun | 2013-08 |
What registrations cannot tell you
Whether results were positive. Whether they were published at all — a large share of registered studies never report outcomes, which biases what the literature appears to show. And whether the product a commercial clinic sells resembles the product studied: cell source, dose, processing and delivery route vary enormously between a registered protocol and an off-protocol injection.
How to use this when someone is selling you a treatment
Ask which specific registered study supports the offer, then compare its intervention description with your quote. If the answer is a general gesture at "Male Infertility research", you are being sold the field's activity rather than evidence about the product. The Provider Question Builder turns that gap into questions.
Frequently asked
How strong is the evidence for stem-cell therapy in Male Infertility?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is thin and mostly exploratory: 15 registered records, 0 at Phase 3/4 and 1 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Check the regulator's own register for the exact product name. Marketing frequently blurs approval for one narrow indication into approval in general.
Why do clinics cite hundreds of studies?
Volume is the cheapest form of credibility. Ask instead for the controlled studies of the specific product, and read what outcome they measured.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.