CompletedNot Applicable

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

Portugal120 participantsStarted 2020-06-12

Plain-language 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.

Who can participate

Age range

18 Years – 48 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pregnancy outcome (spontaneous miscarriage versus evolutive pregnancy) at the first trimester ultrasound

Timeframe: Up to the first trimester ultrasound (11 to 13 weeks plus 6 days of gestation)

Trial details

NCT IDNCT04387994

SponsorInstituto Valenciano de Infertilidade de Lisboa

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2021-12-07

View on ClinicalTrials.gov More Infertility, Female trials