NCT04387994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

June 12, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

May 11, 2020

Last Update Submit

August 3, 2022

Conditions

Infertility, FemaleFirst Trimester Spontaneous Abortion

Keywords

Placental biomarkersIn vitro fertilization (IVF)Pregnancy outcomeMiscarriageEarly predictionIntracytoplasmatic sperm injection (ICSI)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

  • 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)

Interventions

Blood samples collectionOTHER

Collection of blood samples from consenting subjects to evaluate circulating biomarkers concentrations.

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Valenciano de Infertilidade de Lisboa

Lisbon, 1800-282, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected to determine the circulating placental biomarkers concentrations.

MeSH Terms

Conditions

Infertility, FemaleAbortion, Spontaneous

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityPregnancy Complications

Study Officials

  • Tetyana Semenova, MD

    Instituto Valenciano de Infertilidade de Lisboa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 14, 2020

Study Start

June 12, 2020

Primary Completion

December 7, 2021

Study Completion

December 7, 2021

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)