Association Between Plasma Level of Mannose Binding Lectin and Human Reproduction

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169541
• Other study ID #: MBL_reproduction_2022
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

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

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.