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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female; First Trimester Spontaneous Abortion
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 1800-282
    • Instituto Valenciano de Infertilidade de Lisboa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

120 pregnant subjects, confirmed by blood βhCG test, following vitrified-warmed single blastocyst cycles performing IVF/Intracytoplasmic Sperm Injection (ICSI) with autologous oocytes without preimplantation genetic testing for aneuploidies (PGT-A).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidade de Lisboa
• Collaborators: Roche Pharma AG
• Investigators: Principal Investigator: Tetyana Semenova, MD, Instituto Valenciano de Infertilidade de Lisboa

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2020
• Primary Completion (ACTUAL): December 7, 2021
• Study Completion (ACTUAL): December 7, 2021

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (ACTUAL): May 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Miscarriage; In vitro fertilization (IVF); Pregnancy outcome; Early prediction; Placental biomarkers; Intracytoplasmatic sperm injection (ICSI)
• Additional Relevant MeSH Terms: Pregnancy Complications; Infertility; Abortion, Spontaneous; Infertility, Female
• Other Study ID Numbers: 1812-LIS-104-TS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No