Embryo Transfer, Infertilities
Conditions
Brief summary
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.
Interventions
Pregnancies with absence of corpus luteum(PC-FET)
NC-FET(natural cycle FET, endometrial preparation with presence of CL)
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Evaluates the two procedures to become pregnant under study in order to find differences. Two arms and one control group of spontaneous pregnacies.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
Yes
Inclusion criteria
* Female patients 18- 37 years old (both included) at the time of oocyte retrieval and less than 41 years of age at the time of embryo transfer. * Regular menstrual cycles between 24 and 35 days. * Availability of cryopreserved blastocysts from own gametes * Indication for single embryo transfer. * Patients who will be included in the LUTI study are candidates for either of the two procedures under study, and will have no contraindications for either procedure.
Exclusion criteria
* Recurrent pregnancy loss (3 or more). * Recurrent implantation failure in previous IVF treatments (3 or more unsuccessful embryo transfers). . * Diagnosis of polycystic ovarian syndrome, diabetes mellitus, chronic arterial hypertension, maternal heart disease and autoimmune diseases (Systemic Lupus Erythematosus (SLE) or Antiphospholipid syndrome (APS)). * Active treatment with aspirin, heparin or other anticoagulant therapy, antihypertensives or other drugs used to treat circulation or coagulation disorders . * Indication for PGT (Preimplantation Genetic Testing). * Multiple pregnancy.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal endothelial function | Up to 10 month | — |
| Maternal echocardiography: cardiac output (L/min) | Up to 10 month | — |
| Fetal programming | Up to 10 month | Cardiac: sphericity index, longitudinal and transverse heart diameter (mm). |
| Fetal growth | At 12 week of gestation | Fetal crown-rump length (CRL)(cm) |
| Angiogenic/vasoactive function of corpus luteum and placenta | Up to 10 month | — |
| Placental study | At Delivery | 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 |
| Preconceptional parameters | Visit 0 (Baseline) | Both parents: age(years) |
| Maternal Cardivascular Function | Up to 10 month | Plasma NT-proBNP concentration(pg/mL) |
| left ventricular remodeling parameters and total vascular resistance (dyn/sec/cm5). | Up to 10 month | — |
| Neonatal data | At Delivery | Apgar 5' test(parameter/puntuation) |
| plasma concentrations of VCAM-1 and endoglin. | Up to 10 month | — |
Countries
Spain
Contacts
Primary ContactLaura B Burunat, Graduate
Outcome results
None listed