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Immune protein G-CSF put to the test for unexplained recurrent miscarriage

NCT ID NCT07724405

Disease control Sponsor: Fakih IVF Fertility Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests whether a daily injection of granulocyte colony-stimulating factor (G-CSF), a protein that helps regulate the immune system, can improve pregnancy success in women with unexplained recurrent miscarriage after IVF. Only women whose embryos have been genetically confirmed as normal are included, so any pregnancy loss is likely due to the mother's immune response rather than embryo quality. Participants receive either G-CSF or a placebo from embryo transfer until 12 weeks of pregnancy, and the study tracks clinical pregnancy rates at 16 weeks and live birth rates.

What this could mean

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

Active substance
a naturally occurring immune-modulating protein called granulocyte colony-stimulating factor (G-CSF), given as a daily injection
What this could lead to
If it works, this could offer a new treatment for unexplained recurrent miscarriage in women undergoing IVF, potentially improving live birth rates.
What could go wrong
This is a mid-stage trial with 150 participants, so results may not be definitive. G-CSF can cause side effects like bone pain and allergic reactions, and the treatment may not improve pregnancy outcomes.

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

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

18 to 44 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: 1. Women aged 18-44 years 2. ≥2 unexplained pregnancy losses 3. Undergoing IVF with PGT-A tested embryos 4. BMI 19-35 kg/m² 6. Exclusion: 1. Parental karyotype abnormalities 2. Correctable uterine abnormalities 3. Systemic autoimmune disease / thrombophilia 4. Uncontrolled systemic illness (e.g. diabetes, infection) 5. Previous G-CSF therapy 6. Hypersensitivity to rhG-CSF or E. coli proteins 7. HIV, malignancy within 5 years, or severe cardiovascular/respiratory history

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Conditions

The condition(s) this trial relates to.

Abortion, Spontaneous habitual spontaneous abortion pregnancy loss, recurrent, 4 pregnancy loss, recurrent, susceptibility

As listed by the trial registrant

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

Recurrent miscarriages Recurrent pregnancy loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fakih IVF Fertility Centre LLC

    RECRUITING

    Abu Dhabi, United Arab Emirates

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