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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05169541
Other study ID # MBL_reproduction_2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2, 2022
Est. completion date November 30, 2022

Study information

Verified date February 2022
Source Aalborg University Hospital
Contact Caroline Noergaard-Pedersen, M.D.
Phone +4541120267
Email c.noergaardpedersen@rn.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 41 Years
Eligibility 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

Study Design


Locations

Country Name City State
Denmark Aagaard Klinik Aarhus

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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 Odds ratio for a low p-MBL level Comparing prevalence in the patient group with danish female background population (n=185) Blood sample collected after admission when the patient is not pregnant or <9 weeks of gestation.
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