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Could a Blood-Stimulating drug revive failing ovaries?

NCT ID NCT06117982

Disease control Sponsor: Trio Fertility 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This pilot trial tests whether a drug called G-CSF, given as a short course of injections, can improve markers of ovarian reserve in women aged 25-40 with premature ovarian insufficiency (POI). The main question is whether treatment can lower FSH levels, raise AMH, and increase antral follicle count. If these markers improve, participants may be offered IVF to see if eggs and embryos can be obtained. The study aims to explore a potential new way to address infertility linked to POI.

What this could mean

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

Active substance
Filgrastim (G-CSF), given as a subcutaneous injection
What this could lead to
If it works, this could offer a way to restore ovarian function and improve fertility prospects in women with premature ovarian insufficiency.
What could go wrong
This is a small pilot study, so results may not be conclusive. The treatment may not improve ovarian reserve, and risks include side effects from G-CSF.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

11 people

The number who actually took part.

Started

Oct 2023

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

25 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 ages 25-40 * Woman who meet criteria for POI defined as AFC \< 5, AMH \< 3 pmol/L and FSH \>30 IU/L. There may also be associated symptoms of the menopause such as hot flushes, night sweats, insomnia and vaginal dryness. * Women who are not taking any other medical or fertility treatments except natural estrogen to stop hot flushes. * Those who are provided with informed consent. Exclusion Criteria: * Women with age \> 40 * Women with history of autoimmune disorders * Women with a history of hematopoietic cell malignancies * Women with sickle cell disease * Women with any other comorbidities that would preclude infertility treatment and pregnancy such as HIV/AIDS, hepatitis B or C, breast cancer or body mass index (BMI) \>40.

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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 Primary ovarian insufficiency

Contacts and locations

Locations

  • Trio Fertility

    Toronto, Ontario, M5G 2K4, Canada

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