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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples collection | Other | Collection of blood samples from consenting subjects to evaluate circulating biomarkers concentrations. |
| 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) |
| 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 |
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Inclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Semenova, MD | Instituto Valenciano de Infertilidade de Lisboa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Valenciano de Infertilidade de Lisboa | Lisbon | 1800-282 | Portugal |
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Blood samples will be collected to determine the circulating placental biomarkers concentrations.
Measurement of circulating placental biomarkers levels |
| Up to the first trimester ultrasound (11 to 13 weeks plus 6 days of gestation) |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D011248 | Pregnancy Complications |
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