Association Between Plasma Level of Mannose Binding Lectin and Human Reproduction

NCT05169541 | Recruiting

• 1 other identifier: MBL_reproduction_2022
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mannose-Binding Lectin Deficiency; Recurrent Pregnancy Loss; Recurrent Implantation Failure; Infertility; Habitual Abortion; Recurrent Miscarriage; Recurrent Spontaneous Abortion

Outcome Measures

Primary Outcomes (3)

• Low p-MBL level

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

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

• Very low p-MBL level

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

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

• High p-MBL level

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

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

Secondary Outcomes (1)

• Odds ratio for a low p-MBL level

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

Study Arms (3)

Recurrent pregnancy loss after spontaneous conception

Minimum three consecutive losses from pregnancies achieved after spontaneous conception

Recurrent pregnancy loss after assisted reproductive treatment

Minimum three consecutive losses from pregnancies achieved after assisted reproductive treatment (ART), which includes in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), and frozen embryo transfer (FER).

Recurrent implantation failure

Minimum three consecutive embryo transfers (ET) of good quality embryos with no hCG production. The patient must not have experienced any clinical pregnancies (i.e. evidence of pregnancy on an US or by histopathological examination) after IVF or spontaneous conception. Biochemical pregnancies after spontaneous conception, which terminated before evidence of a gestational sac on an ultrasonic scan (US) could be visualized and before the series of RIF occurred, are accepted.

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• fulfil one of the following:
• consecutive pregnancy losses after spontaneous conception
• consecutive pregnancy losses after assisted reproductive technology treatment (ART) including IVF, ICSI and FET
• failed embryo transfers characterized by no achieved pregnancy (after 3 cycles with minimum 1 embryo transfer of a good-quality embryo in each cycle.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aagaard Klinik

Aarhus, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Plasma

MeSH Terms

Conditions

Mannose-Binding Protein Deficiency; Infertility; Abortion, Habitual; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Caroline Nørgaard-Pedersen, M.D.

  Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Noergaard-Pedersen, M.D.

CONTACT

+4541120267; c.noergaardpedersen@rn.dk

Ole B. Christiansen

CONTACT

olbc@rn.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 19, 2021
• First Posted: December 27, 2021
• Study Start: January 1, 2016
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 12 months after article publication and up to 36months only on request.
• Access Criteria: Only on request.

Locations

DK (1)