Infertility, FemaleNCT04387994
Determination of Circulating Placental Biomarkers Levels to Predict the Pregnancy Outcome of First Trimester After IVF.
An observational study of Infertility, Female and First Trimester Spontaneous Abortion, run by Instituto Valenciano de Infertilidade de Lisboa at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, First Trimester Spontaneous Abortion
- What is being tested?
- Blood samples collection
- How many people
- 120 participants
- Where
- 1 sitePortugal
- Study dates
- 12 Jun 2020to 7 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Instituto Valenciano de Infertilidade de Lisboa
Lisbon, 1800-282
About this study
Official title: 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.
Read the 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.
- Being tested
- Blood samples collection
- Keywords
- Placental biomarkers, In vitro fertilization (IVF), Pregnancy outcome, Miscarriage, Early prediction, Intracytoplasmatic sperm injection (ICSI)
- Medical subject headings
- Infertility, Female, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples collectionOther
Collection of blood samples from consenting subjects to evaluate circulating biomarkers concentrations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcome (spontaneous miscarriage versus evolutive pregnancy) at the first trimester ultrasound
Measurement of circulating placental biomarkers levels
Measured: 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)
Measurement of circulating placental biomarkers levels
Measured: 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
Measured: Up to the first trimester ultrasound (11 to 13 weeks plus 6 days of gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start12 Jun 2020
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidade de Lisboa
- Sponsor type
- Research network
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Tetyana Semenova, MD, Principal investigator, Instituto Valenciano de Infertilidade de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387994
- Sponsor's protocol ID
- 1812-LIS-104-TS
- Status last verified
- Aug 2022
- First submitted
- 11 May 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of First Trimester Miscarriage After IVF With Serum Circulating Placental Biomarkers: a Pilot Study to Develop a Prediction Model.
- ClinicalTrials.gov ID
- NCT04387994
- Acronym / sponsor ID
- 1812-LIS-104-TS
- Keywords
- Placental biomarkers, In vitro fertilization (IVF), Pregnancy outcome, Miscarriage, Early prediction, Intracytoplasmatic sperm injection (ICSI)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidade de LisboaResearch network
- Collaborators
- Roche Pharma AG
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples collectionCollection of blood samples from consenting subjects to evaluate circulating biomarkers concentrations. | Other | – |
Primary outcome
Pregnancy outcome (spontaneous miscarriage versus evolutive pregnancy) at the first trimester ultrasound
Time frame: Up to the first trimester ultrasound (11 to 13 weeks plus 6 days of gestation)
Measurement of circulating placental biomarkers levels
2 secondary outcomes
Abnormal outcomes of early pregnancy (biochemical pregnancy and extra uterine pregnancy)
Time frame: 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
Time frame: Up to the first trimester ultrasound (11 to 13 weeks plus 6 days of gestation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetyana Semenova, MD principal investigator
Instituto Valenciano de Infertilidade de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and First Trimester Spontaneous Abortion, run by Instituto Valenciano de Infertilidade de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy outcome (spontaneous miscarriage versus evolutive pregnancy) at the first trimester ultrasound (time frame: Up to the first trimester ultrasound (11 to 13 weeks plus 6 days of gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.