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Blood protein may hold key to unexplained miscarriages and IVF failures

NCT ID NCT05169541

Knowledge-focused Sponsor: Aalborg University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether low levels of a protein called mannose-binding lectin (MBL) in the blood are linked to repeated pregnancy loss or failed IVF attempts. Researchers will measure MBL levels in 500 women with these conditions and compare them to the general population. The goal is to see if MBL deficiency is a common factor in unexplained reproductive failure.

What this could mean

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

What this could lead to
If successful, this could help identify a blood marker to predict reproductive failure risk, guiding future treatments.
What could go wrong
This is an observational study, not a treatment trial. It only measures associations, so it won't directly improve outcomes. Results may not apply to all populations.

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.

Participants

About 500 people

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

Started

Jan 2016

Expected to finish

Nov 2026

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.

Who is studied

Danish female population. The centers cover mainly the western region of Denmark, but patients from all over Denmark can be treated at each center. The Aagaard Klinik is a private IVF clinic and therefore their patients pay for their ART treatments. Patients contact the clinic themself when they need medical support because of reproductive failure. The RPL center at AaUH (public hospital) is available without costs for the patient. Patients are referred from their practitioner or fertility clinic or gynecologist when they have experienced 3 or more pregnancy losses (including biochemical and clinical pregnancies).

Ages

18 to 41 years

Sex

Female participants only

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: fulfil one of the following: * 3 consecutive pregnancy losses after spontaneous conception * 3 consecutive pregnancy losses after assisted reproductive technology treatment (ART) including IVF, ICSI and FET * 3 failed embryo transfers characterized by no achieved pregnancy (after 3 cycles with minimum 1 embryo transfer of a good-quality embryo in each cycle.) Exclusion Criteria: * Age \<18 or \>45 years * AMH \<4.0 pmol/l unless donor egg in previous cycles * Significant uterine malformation * Known endometrial pathologies including intrauterine endometriosis, adenomyosis, hyperplasia or polyps * Known chromosomal abnormalities * Pregnancy \>9 weeks of gestation at the time collecting the blood sample

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Conditions

The condition(s) this trial relates to.

Abortion, Spontaneous habitual spontaneous abortion infertility disorder mannose-binding lectin deficiency 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.

Habitual abortion Infertility Mannose-binding lectin deficiency Recurrent implantation failure Recurrent miscarriage Recurrent pregnancy loss Recurrent spontaneous abortion

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

  • Aagaard Klinik

    RECRUITING

    Aarhus, 8200, Denmark

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