Preimplantation Factor (PIF): Biomarker Detection in Maternal Blood - Correlation With Live Birth.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- BioIncept LLC
- Enrollment
- 500
- Locations
- 5
- Primary Endpoint
- Maternal serum PIF levels correlation with pregnancy viability
Study Overview
Brief Summary
PIF: biomarker of pregnancy, miscarriage, premature birth, preeclampsia, placenta accreta.
Except for serum hCG, no pregnancy-complication markers are widely employed to predict the need for medical intervention. Since circulating PIF is present from very early and throughout viable pregnancy, it may represent a specific biomarker candidate. PIF levels will be analyzed in serum of pregnant women in a range of settings: a) following IVF; b) index pregnancy of women with history of recurrent pregnancy loss, c) index pregnancy of women with history of placenta mediated complications such as: intrauterine growth restriction, spontaneous idiopathic preterm delivery, and preeclampsia; and d) index pregnancy in women with evidence of abnormal placentation, namely placenta accreta and related conditions.
Detailed Description
We will assess PIF prospectively in maternal serum throughout viable pregnancy in order to assess its performance characteristics in predicting viability. More than 250 pregnancies after IVF will be studied as control patients. This PIF longitudinal pregnancy follow up will be compared to those observed for women at risk of pregnancy complications, those with previous such pregnancy.
One objective will be also to define PIF as a biomarker of pregnancy outcome. Then, we will also assess PIF levels in the maternal serum of women with pregnancy complications like miscarriage, preeclampsia, placenta accreta, preterm birth and intrauterine fetal growth restriction.
Our objective is to evaluate PIF maternal serum level in index pregnancy for women with previous pregnancy complications (miscarriage, preeclampsia, intrauterine fetal growth restriction, preterm birth) as listed above and consider at risk pregnancy complication recurrence. Data will be compared with control women (spontaneous pregnancy, singleton gestations, no medical treatment, normal delivery) and pregnant women with SET or MET after IVF.
Prospectively, we will include all patients with a previous pregnancy complications and 100 control women and 200 women after IVF cycles, over 36 months.
PIF assessment will be performed using specific antibody marked with a fluorescent dye, in Luminex® reader.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maternal serum PIF levels correlation with pregnancy viability
Time Frame: up to 12 weeks
Maternal blood will be collected serially following implantation. PIF levels will be recorded. Patients will be followed by standard methods including blood tests and ultrasound until viability is established. Implantation failure (ie chemical pregnancy) miscarriage, evidence of gestational sac will be recorded.
Secondary Outcomes
- Compare pregnancy outcome to low/high PIF levels in maternal blood(up to live birth)