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

Phase 4

Recruiting

• Conditions: Infertilities; Embryo Transfer
• Interventions: Drug: Estradiol + Progesterone; Drug: Ovitrelle ( Hcg 250 mcg)

• Registration Number: NCT06896617
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-05
• Status Verified: 2025-02
• Study Start: 2025-02-01
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-26
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-11-20
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 334

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PC-FET (endometrial preparation with absence of CL)	Estradiol + Progesterone	Pregnancies with absence of corpus luteum
NC-FET (natural cycle FET, endometrial preparation with presence of CL)	Ovitrelle ( Hcg 250 mcg)	Pregnancies with presence of corpus luteum

Primary Outcome Measures

Name	Time	Method
Maternal: Relaxin-2 plasma concentrations.	Up to 10 month
Fetal: Mitral annular plane systolic excursion (MAPSE) assessed by echocardiography.	Up to 10 month

Secondary Outcome Measures

Name	Time	Method
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	Up to 10 month
Maternal echocardiography: cardiac output (L/min)	Up to 10 month
Fetal programming	Up to 10 month	Isovolumetric relaxation time (IRT)(mL/mmHg)
Fetal growth	At 20, 28, 32, and 36 week of gestation.	Study of Fetal Limb Volume (FLV) by 3D-echo (ml)
Neonatal data	At Delivery	Birth weight(kg)
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: illicit substance abuse(Yes/No).
Maternal Cardivascular Function	Up to 10 month	Carotid artery intima-media thickness(mm)
left ventricular remodeling parameters and total vascular resistance (dyn/sec/cm5).	Up to 10 month

Trial Locations

Locations (1)

Laura Burunat; 🇪🇸 Barcelona, Spain