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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513600-33-00 | EU Trial (CTIS) Number |
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In pregnancies achieved through programmed frozen embryo transfer cycle (PC-FET) and modified natural frozen embryo transfer (mNC-FET), to determine whether there are differences in endothelial and placental function, maternal cardiovascular function, fetal growth and fetal cardiovascular and cerebral programming and to assess whether there is an association between these differences and the plasma concentrations of the main secretion products of the Corpus Luteum (CL) with vasoactive and angiogenic action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PC-FET (endometrial preparation with absence of CL) | Active Comparator | Pregnancies with absence of corpus luteum |
|
| NC-FET (natural cycle FET, endometrial preparation with presence of CL) | Active Comparator | Pregnancies with presence of corpus luteum |
|
| Control Arm | No Intervention | Spontaneous pregnancies with no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol + Progesterone | Drug | Pregnancies with absence of corpus luteum(PC-FET) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal: Relaxin-2 plasma concentrations. | Up to 10 month | |
| Fetal: Mitral annular plane systolic excursion (MAPSE) assessed by echocardiography. | Up to 10 month |
| Measure | Description | Time Frame |
|---|---|---|
| Angiogenic/vasoactive function of corpus luteum and placenta | Up to 10 month | |
| plasma concentrations of VCAM-1 and endoglin. | Up to 10 month | |
| Maternal endothelial function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura B Burunat, Graduate | Contact | 0034932275400 | 4198 | burunat@recerca.clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laura Burunat | Recruiting | Barcelona | Spain | 08036 | Spain |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D011374 | Progesterone |
| D006063 | Chorionic Gonadotropin |
| D057073 | Thyrotropin Alfa |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Evaluates the two procedures to become pregnant under study in order to find differences. Two arms and one control group of spontaneous pregnacies.
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| Ovitrelle ( Hcg 250 mcg) | Drug | NC-FET(natural cycle FET, endometrial preparation with presence of CL) |
|
| Up to 10 month |
| Maternal echocardiography: cardiac output (L/min) | Up to 10 month |
| Fetal programming | Cardiac: sphericity index, longitudinal and transverse heart diameter (mm). | Up to 10 month |
| Fetal programming | Cerebral cortex development: Depth of parietooccipital, cingulate and calcarine sulci (mm) corrected by DBP x 100 | Up to 10 month |
| Fetal growth | Fetal crown-rump length (CRL)(cm) | At 12 week of gestation |
| Fetal growth | Biometry (mm) | At 20, 28, 32, and 36 week of gestation. |
| Neonatal data | Apgar 5' test(parameter/puntuation) | At Delivery |
| Placental study | Pregnancy: location of placenta (anterior, posterior, lateral or previa) and signs of placenta accreta spectrum disorders. Anatomopathologycal study of the placenta: weight (fresh, gr.) and histopathology | At Delivery |
| Preconceptional parameters | Both parents: age(years) | Visit 0 (Baseline) |
| Maternal Cardivascular Function | Plasma NT-proBNP concentration(pg/mL) | Up to 10 month |
| left ventricular remodeling parameters and total vascular resistance (dyn/sec/cm5). | Up to 10 month |
| Fetal programming | Transverse and longitudinal diameters and sphericity index of atria and ventricles(mm). | Up to 10 month |
| Fetal programming | Tricuspid annular plane systolic excursion (TAPSE)(mm). | Up to 10 month |
| Fetal programming | Tricuspid annulus tissue Doppler [E', A' and S' wave (cms/s)]. | Up to 10 month |
| Fetal programming | Isovolumetric relaxation time (IRT)(mL/mmHg) | Up to 10 month |
| Fetal growth | Nuchal translucency (NT)(mm) | At 12 week of gestation |
| Fetal growth | ductus venosus pulsatility index (DV-PI)(pencentile) | At 12 week of gestation |
| Fetal growth | Mean uterine artery pulsatility index (mUt-PI)(percentile) | At 12 week of gestation |
| Fetal growth | Biparietal diameter (BPD)(cm) | At 20, 28, 32, and 36 week of gestation. |
| Fetal growth | Head circumference (HC)(cm) | At 20, 28, 32, and 36 week of gestation. |
| Fetal growth | Abdominal circumference (AC)(cm) | At 20, 28, 32, and 36 week of gestation. |
| Fetal growth | Femoral length (FL)(mm) | At 20, 28, 32, and 36 week of gestation. |
| Fetal growth | Estimated fetal weight (g) and centile. | At 20, 28, 32, and 36 week of gestation. |
| Fetal growth | Doppler study of umbilical artery (UA) middle cerebral artery (MCA) and mUt-PI (percentile) | At 20, 28, 32, and 36 week of gestation. |
| Fetal growth | Study of Fetal Limb Volume (FLV) by 3D-echo (ml) | At 20, 28, 32, and 36 week of gestation. |
| Neonatal data | Umbilical artery pH(range) | At Delivery |
| Neonatal data | Birth weight(kg) | At Delivery |
| Preconceptional parameters | Both parents: ethnicity(descriptive) | Visit 0 (Baseline) |
| Preconceptional parameters | Both parents: socioeconomic status(descriptive) | Visit 0 (Baseline) |
| Preconceptional parameters | Both parents: education level(descriptive), | Visit 0 (Baseline) |
| Preconceptional parameters | Both parents: BMI(cm/kg) | Visit 0 (Baseline) |
| Preconceptional parameters | Both parents: chronic diseases(descriptive) | Visit 0 (Baseline) |
| Preconceptional parameters | Both parents: smoking(yes/no) | Visit 0 (Baseline) |
| Preconceptional parameters | Both parents: alcohol consumption(yes/No) | Visit 0 (Baseline) |
| Preconceptional parameters | Both parents: illicit substance abuse(Yes/No). | Visit 0 (Baseline) |
| Maternal Cardivascular Function | Systolic, diastolic and mean arterial blood pressure(mmHg) | Up to 10 month |
| Maternal Cardivascular Function | Carotid artery intima-media thickness(mm) | Up to 10 month |
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D003339 | Corpus Luteum Hormones |
| D045167 | Progesterone Congeners |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D013972 | Thyrotropin |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |