Mannose-binding lectin levels and repeated pregnancy or implantation failure
Official title: Is Plasma Level of Mannose Binding Lectin Associated With Reproductive Failure?
Run by Aalborg University Hospital · NCT05169541 · Data updated 2026-11-12
This project will test whether low blood levels of mannose-binding lectin are linked to repeated pregnancy loss, repeated failed embryo transfers after IVF/ICSI/FET, or other unexplained infertility in people with three consecutive pregnancy failures.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 41 Years |
| Sex | Women only |
| Enrollment | 500 (estimated) |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aarhus) |
| Status | Recruiting |
| Started | January 1, 2016 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT05169541 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People aged 18–45 who have experienced either three consecutive pregnancy losses after spontaneous conception, three consecutive pregnancy losses after ART, or three failed embryo transfers (each cycle with at least one good-quality embryo), and who do not have exclusionary conditions such as major uterine malformations or known chromosomal abnormalities and have AMH ≥4.0 pmol/L unless donor eggs were used.
✕Probably not a fit
People with known causes of reproductive failure (for example parental chromosomal abnormalities, significant uterine or endometrial disease), those with very low ovarian reserve (AMH <4.0 pmol/L without donor eggs), or those unable to attend the Aarhus site are unlikely to benefit from joining this observational project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study measuring plasma mannose-binding lectin (p-MBL) levels in people with recurrent reproductive failure, including recurrent pregnancy loss after spontaneous conception, recurrent pregnancy loss after ART, and recurrent implantation failure after embryo transfer. Participants who meet strict inclusion criteria will have a blood sample taken and their p-MBL level compared with expected background prevalence and across the different reproductive-failure groups. The study excludes people with known chromosomal abnormalities, significant uterine or endometrial pathology, very low ovarian reserve (AMH <4.0 pmol/L unless donor egg used), or pregnancy beyond 9 weeks at sampling. Results will describe how common low or high p-MBL is in these groups and whether patterns differ between RPL, RIF, and ART-related losses.
Why it matters
Potential benefit: If low p-MBL is tied to certain types of reproductive failure, testing could help identify people who might benefit from tailored diagnostic work-ups or targeted management strategies.
How similar studies have gone: Previous research has reported a higher prevalence of low p-MBL in unexplained recurrent pregnancy loss, but its association with recurrent implantation failure and ART-related losses is less studied and this work expands that inquiry.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Aagaard Klinik
Aarhus, Denmark Recruiting
Study contacts
- Principal investigator: Caroline Nørgaard-Pedersen, M.D. — Aalborg University Hospital
- Study coordinator: Caroline Noergaard-Pedersen, M.D.
- Email: c.noergaardpedersen@rn.dk
- Phone: +4541120267
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using prednisolone to help women with unexplained recurrent miscarriages
This study is testing if taking prednisolone can help women who have had multiple unexplained miscarriages have a successful pregnancy.
-
Comparing timing of embryo transfer in women with recurrent implantation failure
This study is testing if timing frozen embryo transfers based on a special test can help women with repeated implantation failures get pregnant more successfully than using the usual timing methods.
-
AI-assisted embryo selection on day 5 in IVF for infertility
This trial tests whether an AI-based embryo selection tool can help pick the best embryo for transfer on day 5 in IVF/ICSI to improve pregnancy chances for people with infertility.
-
Preserving sperm quality with aging through cryopreservation
This study tests whether freezing and thawing sperm can help keep younger-like DNA and molecular traits in men as they age.
-
Unstimulated Egg Retrieval with CAPA-IVM and Euploid Embryo Transfer
This study tests whether eggs can be collected without ovarian stimulation, matured in the lab, and used to create a single euploid embryo for transfer in infertility patients.
-
G-CSF to help women with unexplained recurrent miscarriages
This study tests whether recombinant G-CSF can help women with two or more unexplained miscarriages who are undergoing IVF with tested embryos.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.