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NCT Number: NCT05169541

Association Between Plasma Level of Mannose Binding Lectin and Human Reproduction

A low plasma level of mannose binding lectin (p-MBL) is associated with unexplained recurrent pregnancy loss (RPL), but it is not investigated if it is associated with unexplained reproductive failure in general, including recurrent implantation failure (RIF) after assisted reproductive technology (ART) (including IVF, ICSI and FET), recurrent pregnancy loss (RPL) after spontaneous conception, and RPL after ART.

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Key information

About this study

The prevalence of a low p-MBL level is higher in patients with unexplained RPL than in the background population, while a high level is significantly less frequent in RPL patients (Nørgaard-Pedersen et al., submitted).

Approximately 50% of RPL patients have none of the evidence-based risk factors associated with RPL. Unexplained RPL is more complicated since finding the cause is essential for offering the optimal intervention to improve the patient's chances of a child.

Other conditions characterized by reproductive failure are infertility and recurrent implantation failure (RIF). The underlying mechanisms and the physiologic stage in early pregnancy being complicated and impeding normal pregnancy may probably differ between these pathologic conditions, since theoretically RIF would involve complicated embryo apposition, adhesion and invasion and clinical/visualized pregnancy losses would involve complicated stages later in the implantation process and fetal development. However, these conditions are suggested to have partly overlapping causes since most of the evidence-based risk factor recur; including parental chromosomal abnormalities, and maternal endocrine disorders, acquired thrombophilia, anatomic abnormalities in the uterine cavity, and endometrial and ovarian diseases. In addition, adverse immune responses against the embryo have been suggested as a cause of reproductive failure. If RPL is associated with a low p-MBL level, RIF may be so too.

The investigators aim to explore the p-MBL level in patients suffering from reproductive failure.

If low p-MBL level is associated with all the investigated subgroups of patients suffering from reproductive failure, this would strengthen our theory that MBL is involved in the pathophysiology characterized by reproductive failure in the very early stages of pregnancy and should therefore take part in the exploration of all patients with reproductive failure.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Low p-MBL level

    Time frame: Blood sample collected after admission when the patient is not pregnant or <9 weeks of gestation.

    Low plasma mannose binding lectin level defined as <500 ug/l

  2. Very low p-MBL level

    Time frame: Blood sample collected after admission when the patient is not pregnant or <9 weeks of gestation.

    Very low plasma mannose binding lectin level defined as <100 ug/l

  3. High p-MBL level

    Time frame: Blood sample collected after admission when the patient is not pregnant or <9 weeks of gestation.

    High plasma mannose binding lectin level defined as >3000 ug/l

Secondary outcomes

  1. Odds ratio for a low p-MBL level

    Time frame: Blood sample collected after admission when the patient is not pregnant or <9 weeks of gestation.

    Comparing prevalence in the patient group with danish female background population (n=185)

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Noergaard-Pedersen, M.D.

CONTACT

[email protected]

+4541120267

Ole B. Christiansen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Is Plasma Level of Mannose Binding Lectin Associated With Reproductive Failure?

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2021
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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