Clinical trial NCT06896617: Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET)
Official title: Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET): a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Infertilities
Embryo Transfer
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 334
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maternal: Relaxin-2 plasma concentrations.
timeFrame: Up to 10 month
measure: Fetal: Mitral annular plane systolic excursion (MAPSE) assessed by echocardiography.
timeFrame: Up to 10 month
Secondary outcomes:
measure: Angiogenic/vasoactive function of corpus luteum and placenta
timeFrame: Up to 10 month
measure: plasma concentrations of VCAM-1 and endoglin.
timeFrame: Up to 10 month
measure: Maternal endothelial function
timeFrame: Up to 10 month
measure: Maternal echocardiography: cardiac output (L/min)
timeFrame: Up to 10 month
measure: Fetal programming
timeFrame: Up to 10 month
measure: Fetal programming
timeFrame: Up to 10 month
measure: Fetal growth
timeFrame: At 12 week of gestation
measure: Fetal growth
timeFrame: At 20, 28, 32, and 36 week of gestation.
measure: Neonatal data
timeFrame: At Delivery
measure: Placental study
timeFrame: At Delivery
measure: Preconceptional parameters
timeFrame: Visit 0 (Baseline)
measure: Maternal Cardivascular Function
timeFrame: Up to 10 month
measure: left ventricular remodeling parameters and total vascular resistance (dyn/sec/cm5).
timeFrame: Up to 10 month
measure: Fetal programming
timeFrame: Up to 10 month
measure: Fetal programming
timeFrame: Up to 10 month
measure: Fetal programming
timeFrame: Up to 10 month
measure: Fetal programming
timeFrame: Up to 10 month
measure: Fetal growth
timeFrame: At 12 week of gestation
measure: Fetal growth
timeFrame: At 12 week of gestation
measure: Fetal growth
timeFrame: At 12 week of gestation
measure: Fetal growth
timeFrame: At 20, 28, 32, and 36 week of gestation.
measure: Fetal growth
timeFrame: At 20, 28, 32, and 36 week of gestation.
measure: Fetal growth
timeFrame: At 20, 28, 32, and 36 week of gestation.
measure: Fetal growth
timeFrame: At 20, 28, 32, and 36 week of gestation.
measure: Fetal growth
timeFrame: At 20, 28, 32, and 36 week of gestation.
measure: Fetal growth
timeFrame: At 20, 28, 32, and 36 week of gestation.
measure: Fetal growth
timeFrame: At 20, 28, 32, and 36 week of gestation.
measure: Neonatal data
timeFrame: At Delivery
measure: Neonatal data
timeFrame: At Delivery
measure: Preconceptional parameters
timeFrame: Visit 0 (Baseline)
measure: Preconceptional parameters
timeFrame: Visit 0 (Baseline)
measure: Preconceptional parameters
timeFrame: Visit 0 (Baseline)
measure: Preconceptional parameters
timeFrame: Visit 0 (Baseline)
measure: Preconceptional parameters
timeFrame: Visit 0 (Baseline)
measure: Preconceptional parameters
timeFrame: Visit 0 (Baseline)
measure: Preconceptional parameters
timeFrame: Visit 0 (Baseline)
measure: Preconceptional parameters
timeFrame: Visit 0 (Baseline)
measure: Maternal Cardivascular Function
timeFrame: Up to 10 month
measure: Maternal Cardivascular Function
timeFrame: Up to 10 month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Laura Burunat
Study officials:
References: