Actively Recruiting

Age: 18Years - 41Years
FEMALE
ID05169541

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

Led by Aalborg University Hospital · Updated on 2025-11-24

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the relationship between low plasma mannose binding lectin (p-MBL) levels and unexplained reproductive failures, including recurrent pregnancy loss (RPL) and recurrent implantation failure (RIF). The study focuses on patients with reproductive difficulties after assisted reproductive technologies (ART) such as IVF, ICSI, and frozen embryo transfer (FET), as well as after spontaneous conception. The goal is to better understand if low p-MBL levels contribute broadly to reproductive challenges in early pregnancy stages. The study observes three groups of women: those with three consecutive pregnancy losses after spontaneous conception, three losses after ART treatments, and those who experienced three failed embryo transfers with good-quality embryos but no clinical pregnancy. Blood samples are collected from participants when they are not pregnant or before 9 weeks gestation to measure p-MBL levels, categorizing them as low, very low, or high. Participants undergo assessments including blood sampling to measure p-MBL levels, which are the primary outcomes of interest. Secondary measures include calculating the odds ratios for low p-MBL levels among these groups. The study excludes women outside the age range or with certain uterine or chromosomal conditions. The research aims to clarify p-MBL's role in early pregnancy failure mechanisms, helping future evaluation of reproductive failure cases.

CONDITIONS

Brief Title

Association Between Plasma Level of Mannose Binding Lectin and Human Reproduction

Who Can Participate

Age: 18Years - 41Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 41 years
  • Have experienced three consecutive pregnancy losses after spontaneous conception
  • Have experienced three consecutive pregnancy losses after assisted reproductive technology treatment (IVF, ICSI, FET)
  • Have experienced three failed embryo transfers with good-quality embryos and no clinical pregnancy
Not Eligible

You will not qualify if you...

  • Age below 18 or above 45 years
  • AMH level below 4.0 pmol/l unless donor egg used in previous cycles
  • Significant uterine malformation
  • Known endometrial pathologies such as intrauterine endometriosis, adenomyosis, hyperplasia, or polyps
  • Known chromosomal abnormalities
  • Pregnancy beyond 9 weeks of gestation at time of blood sample collection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single timepoint after screening

Participants provide blood samples to measure plasma levels of mannose binding lectin (p-MBL) when not pregnant or before 9 weeks of gestation.

1 visit (in-person)

Long-term Monitoring

Duration - Up to study completion

Participants are observed for reproductive outcomes and association with p-MBL levels over time.

Follow-up visits as per routine clinical care

Trial Site Locations

Total: 1 location

1

Aagaard Klinik

Aarhus, Denmark, 8200

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Research Team

C

Caroline Noergaard-Pedersen, M.D.

O

Ole B. Christiansen

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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