Infertility Clinical Trial
Official title:
Is Plasma Level of Mannose Binding Lectin Associated With Reproductive Failure?
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aagaard Klinik | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Aalborg University Hospital |
Denmark,
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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