About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
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
Trial 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).
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Low p-MBL level
Low plasma mannose binding lectin level defined as \<500 ug/l
Very low p-MBL level
Very low plasma mannose binding lectin level defined as \<100 ug/l
High p-MBL level
High plasma mannose binding lectin level defined as \>3000 ug/l
Secondary outcomes
Odds ratio for a low p-MBL level
Comparing prevalence in the patient group with danish female background population (n=185)
Sponsors and contacts
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