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Could cell-derived vesicles restart the ovaries? a new trial investigates

NCT ID NCT06202547

Disease control Sponsor: Royan Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This early-phase trial tests whether injecting tiny particles called extracellular vesicles, derived from bone marrow stem cells, directly into the ovary is safe for women with premature ovarian failure. The study includes 10 women aged 20–38 who have had no menstrual period for at least a year and high FSH levels. Researchers will monitor for side effects like abscess and measure hormone changes over 8 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
extracellular vesicles derived from bone marrow mesenchymal stromal cells
What this could lead to
If safe and effective, this approach could restore ovarian function and fertility in women with premature ovarian failure.
What could go wrong
This is an early, small trial focused on safety, not yet proof of effectiveness. The treatment may not restore ovarian function, and risks include infection or abscess from the injection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

10 people

The number who actually took part.

Started

Feb 2023

Finished

Jul 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 38 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women between 20-38 years old * Baseline serum level of follicle stimulating hormone (FSH) higher or equal to 25 IU/l at least twice with an interval of 4 months * At least one year has passed since secondary amenorrhea and premature ovarian failure (POF) diagnosis * Normal karyotype and fragile X messenger ribonucleoprotein 1 (FMR1) gene Exclusion Criteria: * Primary amenorrhea * Congenital anomaly of the ovary * Thyroid disease Immune system diseases such as lupus, etc. * Previous and/or family history of ovarian tumor * Previous and/or family history of suffering from major diseases in the past and present such as cancer * Positive serological evidence regarding previous or current hepatitis B and C, Human T-lymphotropic virus 1, Human immunodeficiency virus (HIV), Syphilis Disturbance in the normal range of laboratory tests as levels of Hemoglobin Subunit Alpha 1 (HbA1), Alanine transaminase (ALT), The aspartate aminotransferase (AST), the number of white blood cells (WBCs), The creatinine (Cr), International normalised ratio (INR) , Platelets (Plt), Hematocrit (Hct) tests. * History of specific systemic disease (rheumatology, endocrine, cardiovascular, etc.) * Severe endometriosis (stage III and IV) * Small and non-injectable ovaries Lack of patient satisfaction * The patient's unwillingness to continue participating in the study

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Conditions

The condition(s) this trial relates to.

premature menopause primary ovarian failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Premature ovarian failure

Contacts and locations

Locations

  • Royan Institute

    Tehran, Tehran Province, Iran

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