Registry evidence

Premature Ovarian Insufficiency and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains

The ClinicalTrials.gov registry holds 9 records for HSCT in Premature Ovarian Insufficiency: 0 recruiting now, 1 labelled Phase 3 or 4, across 7 countries. Snapshot 2026-08-29.

Medical review statusMedically reviewedReviewed by: Stem Plus medical teamReviewed on: 2026-08-29Last evidence update: 2026-08-29Methodology and editorial standards
Clinical review team: Dr Kamelia Milcheva, Hematologist · Dr Vadym Uvarov, Board-Certified Physician · Hepatobiliary Surgeon · Candidate of Medical SciencesEditorial responsibility: StemCellAtlas research teamEducational information only. This page does not provide medical advice, diagnosis or a treatment recommendation.

Why this is studied in Premature Ovarian Insufficiency

Primary ovarian insufficiency is loss of ovarian function before forty, from genetic, autoimmune or iatrogenic causes. Cell and platelet-based 'ovarian rejuvenation' aims to restore folliculogenesis. Occasional spontaneous ovulation occurs in this condition — including spontaneous pregnancies — which is the fact most often exploited by uncontrolled case reports.

What HSCT means in this table

Haematopoietic transplantation is the oldest and most consequential cell therapy in medicine, with conditioning regimens that carry real mortality risk alongside genuine disease-modifying power. Registrations under this label therefore mix decades-old standard-of-care protocols with newer autoimmune-reset trials, and the risk profile is nothing like that of an outpatient infusion.

The numbers

Every figure below comes from one reproducible query (primary ovarian insufficiency x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.

MetricValue
Registered studies (all statuses)9
Interventional studies in the sample9
Recruiting right now0
Completed4
Terminated, withdrawn or suspended0
Phase 3 or Phase 4 records1
Countries with at least one site7
Median planned enrolment51 participants
Largest single planned enrolment200 participants
First / most recent start year2002 — 2025

How mature is this evidence?

A small later-stage tail exists (1 of 9 records at Phase 3 or 4); the centre of gravity is still Phase 1 and 2 work sized for safety rather than proof of benefit.

4 records are marked completed and 0 ended early (terminated, withdrawn or suspended): 0% of registrations did not run to plan.

Phase labelRecordsShare
Phase 2643%
Phase 1536%
Not applicable214%
Phase 417%

Median planned enrolment is 51 participants (largest single study: 200). Trials of this size can describe safety and generate hypotheses; detecting a modest clinical benefit reliably usually needs substantially larger numbers with a control group.

Where the studies are

The work is distributed across 7 countries; Egypt alone accounts for about 33% of mentions, so 'internationally researched' can still mean concentrated in a few regulatory environments.

CountryStudies with a site there
Egypt3
United States1
France1
Spain1
China1
Jordan1
Iran1

Legal pathway differs by country — see where cell therapy is legal, by country.

Who runs them

The sponsor mix is academic (4 academic or hospital, 3 commercial among the most frequent lead sponsors).

  • Al-Azhar University — 2 records
  • M.D. Anderson Cancer Center — 1 record
  • University Hospital, Bordeaux — 1 record
  • Instituto de Investigacion Sanitaria La Fe — 1 record
  • First Affiliated Hospital Xi'an Jiaotong University — 1 record
  • Stem Cells Arabia — 1 record

Representative registered studies

Recruiting studies first, then the most advanced phases. Each identifier links to the registry record, where eligibility criteria, outcome measures and contacts are published.

StudyPhaseStatusPlanned nLead sponsorStart
NCT03535480 — Autologous Bone Marrow Stem Cell Ovarian Transplantation to Restore Ovarian Function in Premature Ovarian FailurePhase 4Unknown20Instituto de Investigacion Sanitaria La Fe2018-06
NCT03069209 — Autologous Bone Marrow-Derived Stem Cell Transplantation in Patients With Premature Ovarian Failure (POF)Phase 1, Phase 2Unknown50Stem Cells Arabia2015-01
NCT02603744 — Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)Phase 1, Phase 2Unknown9Royan Institute2015-06
NCT02043743 — Autologous Stem Cells Transplantation in Patients With Idiopathic and Drug Induced Premature Ovarian FailurePhase 1, Phase 2Unknown60El-Rayadh Fertility Centre2014-01
NCT02372474 — "It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian FailurePhase 1, Phase 2Completed112Al-Azhar University2012-03
NCT02151890 — Pregnancy After Stem Cell Transplantation in Premature Ovarian FailurePhase 1, Phase 2Completed10Al-Azhar University2012-03
NCT00429494 — GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation PatientsPhase 2Completed60M.D. Anderson Cancer Center2002-11
NCT07048730 — Gynecological Impact of Allogeneic Hematopoietic Stem Cell Transplantation in Adultsn/aCompleted51University Hospital, Bordeaux2025-09-19
NCT05667428 — A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCTn/aUnknown200First Affiliated Hospital Xi'an Jiaotong University2023-03-01

What this page does and does not tell you

These figures describe effort, not outcome. Published results, with their control arms and endpoints, are where benefit is decided.

If a clinic offers you this today, the useful question is not "is there research?" but "which of these registered studies is mine part of, and if none, what evidence applies to the exact product I am being sold?" The Provider Question Builder turns that into a scored checklist.

Frequently asked

How many HSCT studies for Premature Ovarian Insufficiency are recruiting right now?

0 of 9 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.

Is HSCT an approved treatment for Premature Ovarian Insufficiency?

Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 9 registered studies tell you research exists, not that a product cleared review.

How advanced is the research on HSCT for Premature Ovarian Insufficiency?

1 of 9 records carry a Phase 3 or Phase 4 label and 4 are marked completed. Registrations run from 2002 to 2025.

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.

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Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.