Status:
COMPLETED
Determination of Circulating Placental Biomarkers Levels to Predict the Pregnancy Outcome of First Trimester After IVF.
Lead Sponsor:
Instituto Valenciano de Infertilidade de Lisboa
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Infertility, Female
First Trimester Spontaneous Abortion
Eligibility:
FEMALE
18-48 years
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...
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 diagn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 12 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04387994
Start Date
June 12 2020
End Date
December 7 2021
Last Update
August 4 2022
Active Locations (1)
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1
Instituto Valenciano de Infertilidade de Lisboa
Lisbon, Portugal, 1800-282