Association Between Plasma Level of Mannose Binding Lectin and Human Reproduction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-41
SponsorAalborg University Hospital

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 3 trial groups
Group A: Recurrent pregnancy loss after spontaneous conception
Group B: Recurrent pregnancy loss after assisted reproductive treatment
Group C: Recurrent implantation failure

Trial outcomes

Primary outcomes

1

Low p-MBL level

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

Time frame
Blood sample collected after admission when the patient is not pregnant or <9 weeks of gestation.
2

Very low p-MBL level

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

Time frame
Blood sample collected after admission when the patient is not pregnant or <9 weeks of gestation.
3

High p-MBL level

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

Time frame
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

Comparing prevalence in the patient group with danish female background population (n=185)

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

Other outcomes

Sponsors and contacts

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