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

Completed

• Conditions: Infertility, Female; First Trimester Spontaneous Abortion

• Registration Number: NCT04387994
• Lead Sponsor: Instituto Valenciano de Infertilidade de Lisboa

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.

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-14
• Study Start: 2020-06-12
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Instituto Valenciano de Infertilidade de Lisboa; 🇵🇹 Lisboa, Portugal