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

NCT06896617 | Recruiting Phase 4

• 1 other identifier: 2024-513600-33-00
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertilities; Embryo Transfer

Outcome Measures

Primary Outcomes (2)

• Maternal: Relaxin-2 plasma concentrations.

  Up to 10 month

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

  Up to 10 month

Secondary Outcomes (39)

• 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

Study Arms (3)

PC-FET (endometrial preparation with absence of CL)

ACTIVE COMPARATOR

Pregnancies with absence of corpus luteum

Drug: Estradiol + Progesterone

NC-FET (natural cycle FET, endometrial preparation with presence of CL)

ACTIVE COMPARATOR

Pregnancies with presence of corpus luteum

Drug: Ovitrelle ( Hcg 250 mcg)

Control Arm

NO INTERVENTION

Spontaneous pregnancies with no intervention

Interventions

Estradiol + Progesterone DRUG

Pregnancies with absence of corpus luteum(PC-FET)

PC-FET (endometrial preparation with absence of CL)

Ovitrelle ( Hcg 250 mcg) DRUG

NC-FET(natural cycle FET, endometrial preparation with presence of CL)

NC-FET (natural cycle FET, endometrial preparation with presence of CL)

Eligibility Criteria

• Age: 18 Years - 41 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

Laura Burunat

Barcelona, Spain, 08036, Spain

RECRUITING

MeSH Terms

Interventions

Estradiol; Progesterone; Chorionic Gonadotropin; Thyrotropin Alfa

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners; Gonadotropins; Peptide Hormones; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones

Central Study Contacts

Laura B Burunat, Graduate

CONTACT

0034932275400; burunat@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluates the two procedures to become pregnant under study in order to find differences. Two arms and one control group of spontaneous pregnacies.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: March 26, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-02

Locations

ES (1)