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

March 28, 2025 updated by: Fundacion Clinic per a la Recerca Biomédica

Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET): a Prospective Randomized Controlled Study

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
334

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Laura Burunat
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: PC-FET (endometrial preparation with absence of CL)
Pregnancies with absence of corpus luteum
Drug: Estradiol + Progesterone
Pregnancies with absence of corpus luteum(PC-FET)
Active Comparator: NC-FET (natural cycle FET, endometrial preparation with presence of CL)
Pregnancies with presence of corpus luteum
Drug: Ovitrelle ( Hcg 250 mcg)
NC-FET(natural cycle FET, endometrial preparation with presence of CL)
No Intervention: Control Arm
Spontaneous pregnancies with no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maternal: Relaxin-2 plasma concentrations.
Time Frame: Up to 10 month
Up to 10 month
Fetal: Mitral annular plane systolic excursion (MAPSE) assessed by echocardiography.
Time Frame: Up to 10 month
Up to 10 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Angiogenic/vasoactive function of corpus luteum and placenta
Time Frame: Up to 10 month
Up to 10 month
plasma concentrations of VCAM-1 and endoglin.
Time Frame: Up to 10 month
Up to 10 month
Maternal endothelial function
Time Frame: Up to 10 month
Up to 10 month
Maternal echocardiography: cardiac output (L/min)
Time Frame: Up to 10 month
Up to 10 month
Fetal programming
Time Frame: Up to 10 month
Cardiac: sphericity index, longitudinal and transverse heart diameter (mm).
Up to 10 month
Fetal programming
Time Frame: Up to 10 month
Cerebral cortex development: Depth of parietooccipital, cingulate and calcarine sulci (mm) corrected by DBP x 100
Up to 10 month
Fetal growth
Time Frame: At 12 week of gestation
Fetal crown-rump length (CRL)(cm)
At 12 week of gestation
Fetal growth
Time Frame: At 20, 28, 32, and 36 week of gestation.
Biometry (mm)
At 20, 28, 32, and 36 week of gestation.
Neonatal data
Time Frame: At Delivery
Apgar 5' test(parameter/puntuation)
At Delivery
Placental study
Time Frame: 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
At Delivery
Preconceptional parameters
Time Frame: Visit 0 (Baseline)
Both parents: age(years)
Visit 0 (Baseline)
Maternal Cardivascular Function
Time Frame: Up to 10 month
Plasma NT-proBNP concentration(pg/mL)
Up to 10 month
left ventricular remodeling parameters and total vascular resistance (dyn/sec/cm5).
Time Frame: Up to 10 month
Up to 10 month
Fetal programming
Time Frame: Up to 10 month
Transverse and longitudinal diameters and sphericity index of atria and ventricles(mm).
Up to 10 month
Fetal programming
Time Frame: Up to 10 month
Tricuspid annular plane systolic excursion (TAPSE)(mm).
Up to 10 month
Fetal programming
Time Frame: Up to 10 month
Tricuspid annulus tissue Doppler [E', A' and S' wave (cms/s)].
Up to 10 month
Fetal programming
Time Frame: Up to 10 month
Isovolumetric relaxation time (IRT)(mL/mmHg)
Up to 10 month
Fetal growth
Time Frame: At 12 week of gestation
Nuchal translucency (NT)(mm)
At 12 week of gestation
Fetal growth
Time Frame: At 12 week of gestation
ductus venosus pulsatility index (DV-PI)(pencentile)
At 12 week of gestation
Fetal growth
Time Frame: At 12 week of gestation
Mean uterine artery pulsatility index (mUt-PI)(percentile)
At 12 week of gestation
Fetal growth
Time Frame: At 20, 28, 32, and 36 week of gestation.
Biparietal diameter (BPD)(cm)
At 20, 28, 32, and 36 week of gestation.
Fetal growth
Time Frame: At 20, 28, 32, and 36 week of gestation.
Head circumference (HC)(cm)
At 20, 28, 32, and 36 week of gestation.
Fetal growth
Time Frame: At 20, 28, 32, and 36 week of gestation.
Abdominal circumference (AC)(cm)
At 20, 28, 32, and 36 week of gestation.
Fetal growth
Time Frame: At 20, 28, 32, and 36 week of gestation.
Femoral length (FL)(mm)
At 20, 28, 32, and 36 week of gestation.
Fetal growth
Time Frame: At 20, 28, 32, and 36 week of gestation.
Estimated fetal weight (g) and centile.
At 20, 28, 32, and 36 week of gestation.
Fetal growth
Time Frame: At 20, 28, 32, and 36 week of gestation.
Doppler study of umbilical artery (UA) middle cerebral artery (MCA) and mUt-PI (percentile)
At 20, 28, 32, and 36 week of gestation.
Fetal growth
Time Frame: At 20, 28, 32, and 36 week of gestation.
Study of Fetal Limb Volume (FLV) by 3D-echo (ml)
At 20, 28, 32, and 36 week of gestation.
Neonatal data
Time Frame: At Delivery
Umbilical artery pH(range)
At Delivery
Preconceptional parameters
Time Frame: Visit 0 (Baseline)
Both parents: ethnicity(descriptive)
Visit 0 (Baseline)
Preconceptional parameters
Time Frame: Visit 0 (Baseline)
Both parents: socioeconomic status(descriptive)
Visit 0 (Baseline)
Preconceptional parameters
Time Frame: Visit 0 (Baseline)
Both parents: education level(descriptive),
Visit 0 (Baseline)
Preconceptional parameters
Time Frame: Visit 0 (Baseline)

Both parents:

BMI(cm/kg)
Visit 0 (Baseline)
Preconceptional parameters
Time Frame: Visit 0 (Baseline)
Both parents: chronic diseases(descriptive)
Visit 0 (Baseline)
Preconceptional parameters
Time Frame: Visit 0 (Baseline)
Both parents: smoking(yes/no)
Visit 0 (Baseline)
Preconceptional parameters
Time Frame: Visit 0 (Baseline)
Both parents: alcohol consumption(yes/No)
Visit 0 (Baseline)
Preconceptional parameters
Time Frame: Visit 0 (Baseline)
Both parents: illicit substance abuse(Yes/No).
Visit 0 (Baseline)
Maternal Cardivascular Function
Time Frame: Up to 10 month
Systolic, diastolic and mean arterial blood pressure(mmHg)
Up to 10 month
Maternal Cardivascular Function
Time Frame: Up to 10 month
Carotid artery intima-media thickness(mm)
Up to 10 month
Neonatal data
Time Frame: At Delivery
Birth weight(kg)
At Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion Clinic per a la Recerca Biomédica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-513600-33-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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