Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET)

Phase 4RecruitingNCT06896617

Fundacion Clinic per a la Recerca Biomédica334 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

334

Conditions

Infertilities Embryo Transfer

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 41 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Maternal: Relaxin-2 plasma concentrations.

Time frame: Up to 10 month

Fetal: Mitral annular plane systolic excursion (MAPSE) assessed by echocardiography.

Time frame: Up to 10 month

Secondary Outcomes

Angiogenic/vasoactive function of corpus luteum and placenta

Time frame: Up to 10 month

plasma concentrations of VCAM-1 and endoglin.

Time frame: Up to 10 month

Maternal endothelial function

Time frame: Up to 10 month

Maternal echocardiography: cardiac output (L/min)

Time frame: Up to 10 month

Fetal programming

Cardiac: sphericity index, longitudinal and transverse heart diameter (mm).

Time frame: Up to 10 month

Fetal programming

Cerebral cortex development: Depth of parietooccipital, cingulate and calcarine sulci (mm) corrected by DBP x 100

Time frame: Up to 10 month

Fetal growth

Fetal crown-rump length (CRL)(cm)

Time frame: At 12 week of gestation

Fetal growth

Biometry (mm)

Time frame: At 20, 28, 32, and 36 week of gestation.

Neonatal data

Apgar 5' test(parameter/puntuation)

Time frame: 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

Time frame: At Delivery

Preconceptional parameters

Both parents: age(years)

Time frame: Visit 0 (Baseline)

Maternal Cardivascular Function

Plasma NT-proBNP concentration(pg/mL)

Time frame: Up to 10 month

left ventricular remodeling parameters and total vascular resistance (dyn/sec/cm5).

Time frame: Up to 10 month

Fetal programming

Transverse and longitudinal diameters and sphericity index of atria and ventricles(mm).

Time frame: Up to 10 month

Fetal programming

Tricuspid annular plane systolic excursion (TAPSE)(mm).

Time frame: Up to 10 month

Fetal programming

Tricuspid annulus tissue Doppler \[E', A' and S' wave (cms/s)\].

Time frame: Up to 10 month

Fetal programming

Isovolumetric relaxation time (IRT)(mL/mmHg)

Time frame: Up to 10 month

Fetal growth

Nuchal translucency (NT)(mm)

Time frame: At 12 week of gestation

Fetal growth

ductus venosus pulsatility index (DV-PI)(pencentile)

Time frame: At 12 week of gestation

Fetal growth

Mean uterine artery pulsatility index (mUt-PI)(percentile)

Time frame: At 12 week of gestation

Fetal growth

Biparietal diameter (BPD)(cm)

Time frame: At 20, 28, 32, and 36 week of gestation.

Fetal growth

Head circumference (HC)(cm)

Time frame: At 20, 28, 32, and 36 week of gestation.

Fetal growth

Abdominal circumference (AC)(cm)

Time frame: At 20, 28, 32, and 36 week of gestation.

Fetal growth

Femoral length (FL)(mm)

Time frame: At 20, 28, 32, and 36 week of gestation.

Fetal growth

Estimated fetal weight (g) and centile.

Time frame: 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)

Time frame: At 20, 28, 32, and 36 week of gestation.

Fetal growth

Study of Fetal Limb Volume (FLV) by 3D-echo (ml)

Time frame: At 20, 28, 32, and 36 week of gestation.

Neonatal data

Umbilical artery pH(range)

Time frame: At Delivery

Neonatal data

Birth weight(kg)

Time frame: At Delivery

Preconceptional parameters

Both parents: ethnicity(descriptive)

Time frame: Visit 0 (Baseline)

Preconceptional parameters

Both parents: socioeconomic status(descriptive)

Time frame: Visit 0 (Baseline)

Preconceptional parameters

Both parents: education level(descriptive),

Time frame: Visit 0 (Baseline)

Preconceptional parameters

Both parents: BMI(cm/kg)

Time frame: Visit 0 (Baseline)

Preconceptional parameters

Both parents: chronic diseases(descriptive)

Time frame: Visit 0 (Baseline)

Preconceptional parameters

Both parents: smoking(yes/no)

Time frame: Visit 0 (Baseline)

Preconceptional parameters

Both parents: alcohol consumption(yes/No)

Time frame: Visit 0 (Baseline)

Preconceptional parameters

Both parents: illicit substance abuse(Yes/No).

Time frame: Visit 0 (Baseline)

Maternal Cardivascular Function

Systolic, diastolic and mean arterial blood pressure(mmHg)

Time frame: Up to 10 month

Maternal Cardivascular Function

Carotid artery intima-media thickness(mm)

Time frame: Up to 10 month

Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts