CHORIOGONADOTROPIN ALFA for Infertility

Inclusion criteria

• {"criterion_text":"-Female patients ​18-​​​37 years o​ld​​​(both included)​ at the time of oocyte retrieval and less than 41 years of age at the time of embryo transfer.​"}
• {"criterion_text":"-Regular menstrual cycle​s​ between 24 and 35 days."}
• {"criterion_text":"-Availability of cryopreserved blastocysts from own gametes"}
• {"criterion_text":"-Indication for ​​single embryo​ transfer​."}

Exclusion criteria

• {"criterion_text":"-​​​Recurrent pregnancy loss (3 or more).​​"}
• {"criterion_text":"-​Recurrent implantation failure in previous IVF treatments (3 or more unsuccessful embryo transfers)"}
• {"criterion_text":"-Diagnosis of polycystic ovarian syndrome, diabetes mellitus, chronic arterial hypertension, maternal heart disease and autoimmune disease​s (Systemic Lupus Erythematosus (SLE) or Antiphospholipid syndrome (APS))"}
• {"criterion_text":"-Active treatment with ​aspirin, heparin or other anticoagulant​ therapy, antihypertensives or other drugs ​used to treat circulation or coagulation disorders ​."}
• {"criterion_text":"-Indication for PGT (Preimplantation Genetic Testing)."}
• {"criterion_text":"-Multiple ​pregnancy​."}

Primary endpoints

• {"endpoint_text":"-Maternal: Relaxin-2 plasma concentration​s​.","definition_or_measurement_approach":"Measurement of maternal plasma concentrations of relaxin-2."}
• {"endpoint_text":"-Fetal: Mitral annular plane systolic excursión (MAPSE) assessed by echocardiography.","definition_or_measurement_approach":"Assessment of fetal MAPSE by echocardiography."}

Secondary endpoints

• {"endpoint_text":"-Angiogenic/vasoactive function of ​CL​​ and placenta: plasma concentration​s​ of VEGF-A, sFlt-1, PlGF progesterone, beta-hCG.​ ​","definition_or_measurement_approach":"Measurement of plasma concentrations of VEGF-A, sFlt-1, PlGF, progesterone and beta-hCG."}
• {"endpoint_text":"-Maternal endothelial function:​​ ​​plasma concentration​s​ of VCAM-1 and endoglin.","definition_or_measurement_approach":"Measurement of plasma concentrations of VCAM-1 and endoglin."}
• {"endpoint_text":"-ICAM-1 and VCAM-1 on the endothelial cells (EC) surface, VE-Cadherin at the EC junctions, intracellular endothelial nitric oxide synthase in EC, von Willebrand Factor in the extracellular matrix (ECM), thrombomodulin in ECM, tissue factor in ECM","definition_or_measurement_approach":"Assessment of endothelial cell surface and extracellular matrix markers (ICAM-1, VCAM-1, VE-Cadherin, eNOS, von Willebrand Factor, thrombomodulin, tissue factor) as described."}
• {"endpoint_text":"-Intracellular activation of ERK1/2, p38MAPK, SAPK/JNL and AKT. Fluorescent microspheres (permeability assay). EC proliferation-tube formation (angiogenesis assay).","definition_or_measurement_approach":"Laboratory assays assessing intracellular activation of signalling proteins (ERK1/2, p38MAPK, SAPK/JNL, AKT); permeability assay with fluorescent microspheres; endothelial cell proliferation and tube-formation angiogenesis assays."}
• {"endpoint_text":"-Maternal cardiovascular function: Plasma NT-proBNP concentration.","definition_or_measurement_approach":"Measurement of plasma NT-proBNP concentration."}
• {"endpoint_text":"-Systolic, diastolic and mean arterial blood pressure (mmHg).","definition_or_measurement_approach":"Measurement of systolic, diastolic and mean arterial blood pressure in mmHg."}
• {"endpoint_text":"-Carotid artery intima-media thickness (mm).","definition_or_measurement_approach":"Measurement of carotid artery intima-media thickness in mm."}
• {"endpoint_text":"-Maternal echocardiography: cardiac output (L/min), left ventricular remodeling parameters and total vascular resistance (dyn/sec/cm5).","definition_or_measurement_approach":"Maternal echocardiography to assess cardiac output (L/min), left ventricular remodelling parameters and total vascular resistance."}
• {"endpoint_text":"-Fetal programming: Cardiac: sphericity index, longitudinal and transverse heart diameter (mm).","definition_or_measurement_approach":"Fetal cardiac measurements (sphericity index, longitudinal and transverse heart diameters in mm) by fetal imaging."}
• {"endpoint_text":"-Transverse and longitudinal diameters and sphericity index of atria and ventricles. Tricuspid annular plane systolic excursion (TAPSE)(mm). Tricuspid annulus tissue Doppler [E', A' and S' wave (cms/s)]. Isovolumetric relaxation time (IRT)","definition_or_measurement_approach":"Fetal cardiac structural and functional measurements including diameters, sphericity indices, TAPSE (mm), tissue Doppler velocities (E', A', S' in cm/s) and IRT."}
• {"endpoint_text":"-Cerebral cortex development: Depth of parietooccipital, cingulate and calcarine sulci (mm) corrected by DBP x 100. ​​","definition_or_measurement_approach":"Measurement of depths of parietooccipital, cingulate and calcarine sulci (mm) corrected by DBP x 100."}
• {"endpoint_text":"-Fetal growth. First trimester: fetal crown-rump length (CRL), nuchal translucency (NT), ductus venosus pulsatility index (DV-PI), mean uterine artery pulsatility index (mUt-PI).","definition_or_measurement_approach":"First trimester fetal measurements: CRL, NT, DV-PI, mUt-PI via ultrasound/Doppler."}
• {"endpoint_text":"-Fetal growth ultrasound (second and third trimester): 1) Biometry (mm): biparietal diameter (BPD), head circumference (HC), abdominal circumference (AC) and femoral length (FL).","definition_or_measurement_approach":"Second/third trimester fetal biometry: BPD, HC, AC, FL measured by ultrasound."}
• {"endpoint_text":"-2) Estimated fetal weight (g) and centile.","definition_or_measurement_approach":"Estimated fetal weight in grams and centile by standard ultrasound formulas."}
• {"endpoint_text":"-3) Doppler study of umbilical artery (UA), middle cerebral artery (MCA) and mUt-PI.","definition_or_measurement_approach":"Doppler assessment of UA, MCA and mean uterine artery pulsatility index (mUt-PI)."}
• {"endpoint_text":"-4) Study of Fetal Limb Volume (FLV) by 3D-echo (ml). ​​","definition_or_measurement_approach":"Measurement of fetal limb volume (ml) by 3D echography."}
• {"endpoint_text":"-Neonatal data: Apgar 5', umbilical artery pH, gender, birth weight and centile based on our population normality","definition_or_measurement_approach":"Collection of neonatal outcomes including Apgar at 5 minutes, umbilical artery pH, sex, birth weight and centile referenced to study population norms."}
• {"endpoint_text":"-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","definition_or_measurement_approach":"Placental location and signs of accreta spectrum during pregnancy; post-delivery placental weight (fresh, g) and histopathological examination."}
• {"endpoint_text":"-Preconceptional parameters: ​​ ​​​Both parents: age, ethnicity, socioeconomic status, education level, BMI, chronic diseases, smoking, alcohol consumption, illicit substance abuse.","definition_or_measurement_approach":"Collection of preconceptional parental demographic and lifestyle parameters (age, ethnicity, SES, education, BMI, chronic diseases, smoking, alcohol, illicit substance use)."}
• {"endpoint_text":"-Infertility and IVF data: number of previous pregnancies, previous obstetric complications, smoking during pregnancy, alcohol or illicit drugs consumption during pregnancy, infertility etiology, infertility length, number of previous unsuccessful embryo transfers","definition_or_measurement_approach":"Collection of infertility and IVF history data including prior pregnancies, obstetric complications, substance exposures, infertility etiology and duration, and prior unsuccessful embryo transfers."}
• {"endpoint_text":"-Ovarian stimulation protocol, gonadotrophin dose, ovarian stimulation duration, estradiol at trigger day, number of follicles at trigger, number of oocytes, number of MII, fertilization technique","definition_or_measurement_approach":"Collection of ovarian stimulation and cycle metrics: protocol, gonadotrophin dose and duration, estradiol at trigger, follicle and oocyte counts, MII count, and fertilization technique."}
• {"endpoint_text":"-Number of embryos, number of blastocysts, period of vitrification, transferred blastocyst quality. ​Lifestyle questionaries: PREDIMED, IPAQ, WHO-5, PSS-14, PSQI, , HDRS, FertiQol.​​","definition_or_measurement_approach":"Recording embryology outcomes (embryo and blastocyst counts, vitrification duration, blastocyst quality) and collection of lifestyle/questionnaire data (PREDIMED, IPAQ, WHO-5, PSS-14, PSQI, HDRS, FertiQol)."}

Spain

Earliest CTIS Part Ii Submission Date

18-10-2024

Latest Decision Or Authorization Date

23-10-2024

Processing Time Days

5

Number Of Sites

1

Number Of Participants

240

Primary sponsor

Full Name

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Instituto de Salud Carlos III","duties_or_roles":"Source of monetary support","organisation_type":""}