First Trimester Spontaneous Abortion, Infertility, Female
Conditions
Keywords
Placental biomarkers, In vitro fertilization (IVF), Pregnancy outcome, Miscarriage, Early prediction, Intracytoplasmatic sperm injection (ICSI)
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.
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.
Interventions
Collection of blood samples from consenting subjects to evaluate circulating biomarkers concentrations.
Sponsors
Roche Pharma AG
Instituto Valenciano de Infertilidade de Lisboa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: ≥18 and \<49 years old * Body Mass Index (BMI): ≥18.5 Kg/m2 and \<30 Kg/m2 * Pregnancy resulting from Assisted Reproductive Technologies (ART) * Single blastocyst transfer pregnancy * Pregnancy confirmed by blood test * Gestational age \< 6 weeks at the first US * Signed and dated informed consent
Exclusion criteria
* Spontaneous pregnancies * Treatment for prevention of miscarriage (i.e. corticoids, aspirin, heparin) * Those unable to provide the 11th-13th week ultrasound report * Those unable to comprehend the investigational nature of the proposed study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Portugal
Outcome results
None listed