How strong is the evidence for stem-cell therapy in Premature Ovarian Insufficiency?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is active but still early, with limited late-phase registration: the registry holds 36 records, 11 completed, 3 at Phase 3 or 4, and 5 stopped early (14%). MSC-specific work accounts for 18 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 Premature Ovarian Insufficiency
Only follicle development, ovulation, clinical pregnancy and live birth count, reported against the concurrent IVF protocol. A rise in AMH or a resumed period in a condition with documented spontaneous fluctuation is not evidence of restored fertility.
What we can say from registrations alone
- Volume: 36 registered studies since 2002.
- Maturity: 3 confirmatory-phase records.
- Delivery: 11 completed; 5 terminated, withdrawn or suspended.
- Scale: median planned enrolment 40 participants, largest 320.
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 |
|---|---|---|---|---|---|
| NCT02372474 — "It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure | Phase 1, Phase 2 | Completed | 112 | Al-Azhar University | 2012-03 |
| NCT04675970 — Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy | n/a | Completed | 86 | Ukraine Association of Biobank | 2020-09-01 |
| NCT00429494 — GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients | Phase 2 | Completed | 60 | M.D. Anderson Cancer Center | 2002-11 |
| NCT07048730 — Gynecological Impact of Allogeneic Hematopoietic Stem Cell Transplantation in Adults | n/a | Completed | 51 | University Hospital, Bordeaux | 2025-09-19 |
| NCT04475744 — 4-step ASCOT in POI Women to Promote Follicular Rescue | Phase 3 | Completed | 42 | Fundación IVI | 2021-03-05 |
| NCT02644447 — Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF | Phase 1, Phase 2 | Completed | 23 | Chinese Academy of Sciences | 2015-10 |
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 "Premature Ovarian Insufficiency 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 Premature Ovarian Insufficiency?
ClinicalTrials.gov registrations alone cannot establish how strong the evidence is. Registry activity is active but still early, with limited late-phase registration: 36 registered records, 3 at Phase 3/4 and 5 stopped early (2026-08-29).
Has any stem-cell product been approved for this condition?
Look it up at source: regulators publish authorised products and indications. Registration of a trial, a licence to operate a clinic and product approval are three different things.
Why do clinics cite hundreds of studies?
Because counting registrations is easy and sounds authoritative. The number that matters is how many controlled studies reported a clinically meaningful outcome for the product being sold.
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.
More on this condition
- Premature Ovarian Insufficiency: cell-therapy evidence and registered trials
- How much does stem cell therapy for Premature Ovarian Insufficiency cost? (2026)
- Premature Ovarian Insufficiency stem cell therapy — your questions answered (2026)
- Premature Ovarian Insufficiency: cell-therapy evidence by therapy class
- MSC vs PRP for Premature Ovarian Insufficiency: what the registries show