What research stage is stem-cell therapy for Male Infertility at?
Confirmatory-phase work accounts for 0 of the 15 records here; the remainder is dose-finding, safety or observational (2026-08-29).
Phase distribution
| Phase label | Records | Share |
|---|---|---|
| Not applicable | 8 | 42% |
| Phase 2 | 6 | 32% |
| Phase 1 | 5 | 26% |
What the phase mix means for Male Infertility
The registered base is early and small. Given that a definitive endpoint exists, the absence of later-phase work is itself informative about how the science currently stands.
The later-phase studies themselves
No registered study for this condition carries a Phase 3 or Phase 4 label in this snapshot. That is the single most useful fact on this page: the confirmatory stage has not been reached.
How to read phase labels
The ladder runs from tolerability through signal-finding to a controlled, adequately powered test of benefit. Cell-therapy records frequently carry no phase at all, because observational designs and some tissue-based protocols sit outside the drug framework entirely. Read that as a classification gap, not a verdict.
Median planned enrolment across sampled studies here is 60 participants. Small single-arm studies can flag safety problems; they cannot separate a treatment effect from natural fluctuation, placebo response or regression to the mean.
The largest studies by planned enrolment
Size is a crude proxy for what a study can detect, but it separates a serious attempt from a case series presented as evidence.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT02641769 — Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility. | Phase 1, Phase 2 | Recruiting | 600 | Stem Cells Arabia | 2014-01 |
| 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 |
| NCT06841861 — Spermatogonial Differentiation Via Testicular Organoid | Phase 1, Phase 2 | Recruiting | 100 | CellARTs Inc. | 2024-03-28 |
| NCT02380755 — Clomiphene Citrate for the Treatment of Obesity Related Male Hypogonadism | Phase 2 | Completed | 78 | University of Sao Paulo | 2015-04 |
Frequently asked
What research stage is stem-cell therapy for Male Infertility at?
0 of 15 records are labelled Phase 3 or 4 (2026-08-29).
Is a Phase 3 trial proof that it works?
No — it is a design capable of testing that question. Proof depends on the reported result, replication, and whether the outcome measured matters to patients.
Why do so many records have no phase?
Observational studies and some cell-therapy protocols are registered without a phase label. It is a registry field, not a quality rating.
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.