Determination of Circulating Placental Biomarkers Levels to Predict the Pregnancy Outcome of First Trimester After IVF.

Sponsor

Instituto Valenciano de Infertilidade de Lisboa (Other)

Overall Status

Completed

CT.gov ID

NCT04387994

Collaborator

Roche Pharma AG (Industry)

120

Enrollment

Location

17.8

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the predictive potential of circulating placental biomarkers for spontaneous miscarriage within the following month in an IVF setting. It is hypothesized that a robust algorithm including one or more of these biomarkers may allow for the accurate same-day distinction between women with a low and high risk of a spontaneous miscarriage.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female First Trimester Spontaneous Abortion	Other: Blood samples collection

Detailed Description

Spontaneous miscarriage is the most common adverse outcome in the first trimester of pregnancy. This is a particularly stressful situation for the expecting parents, since their need for a final diagnosis is frustrated for a potentially extended period on time which may span over several weeks. The emotional impact of this complication can be devastating, resulting frequently in depression and anxiety which may last for several months.

In an attempt to allow for an earlier and more accurate diagnosis of first trimester miscarriage, multiple circulating placental biomarkers have been tested over last years. However, their potential usefulness in an everyday clinical setting remains unclear.

The investigators propose a single-center observational prospective cohort study in an in vitro fertilization (IVF) setting. All recruited consenting patients will collect blood samples on a day of the first pregnancy test (12-14 days after embryo transfer) and at the time of the first (at 5 weeks plus 4-5 days of gestational age) and second (at 7 weeks plus 4-5 days of gestational age) ultrasound scan to determine the circulating placental biomarkers concentrations in order to predict the pregnancy outcome (spontaneous miscarriage versus evolutive pregnancy) until the first obstetrical ultrasound, performed between 11 weeks and 13 weeks plus 6 days of gestational age.

Study Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Early Prediction of First Trimester Miscarriage After IVF With Serum Circulating Placental Biomarkers: a Pilot Study to Develop a Prediction Model.

Actual Study Start Date :

Jun 12, 2020

Actual Primary Completion Date :

Dec 7, 2021

Actual Study Completion Date :

Dec 7, 2021

Outcome Measures

Primary Outcome Measures

Pregnancy outcome (spontaneous miscarriage versus evolutive pregnancy) at the first trimester ultrasound [Up to the first trimester ultrasound (11 to 13 weeks plus 6 days of gestation)]
Measurement of circulating placental biomarkers levels

Secondary Outcome Measures

Abnormal outcomes of early pregnancy (biochemical pregnancy and extra uterine pregnancy) [Up to the first trimester ultrasound (11 to 13 weeks plus 6 days of gestation)]
Measurement of circulating placental biomarkers levels
Risk of obstetric complications/adverse outcomes for first-trimester spontaneous miscarriage [Up to the first trimester ultrasound (11 to 13 weeks plus 6 days of gestation)]
Measurement of circulating placental biomarkers levels