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InfertilitiesPhase 4LUTINCT06896617

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

A Phase 4 study testing Estradiol + Progesterone and Ovitrelle ( Hcg 250 mcg) in people with Infertilities and Embryo Transfer, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 41 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertilities, Embryo Transfer
What is being tested?
Estradiol + Progesterone and Ovitrelle ( Hcg 250 mcg)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
1 siteSpain
Study dates
1 Feb 2025to 20 Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 41 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Laura B Burunat, Graduate contact

0034932275400 ext. 4198

burunat@recerca.clinic.cat

Spain1 site, 1 recruiting

  • Laura Burunat

    Barcelona, Spain, 08036

    Laura Burunat Ruesgas, Chemistry, 0034932275400 ext. 4198, burunat@recerca.clinic.cat

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Being tested
Estradiol + Progesterone, Ovitrelle ( Hcg 250 mcg)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Estradiol + ProgesteroneDrug

    Pregnancies with absence of corpus luteum(PC-FET)

  • Ovitrelle ( Hcg 250 mcg)Drug

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

Study groups in NCT06896617
Study groupRoleWhat they receive
PC-FET (endometrial preparation with absence of CL)Active comparatorPregnancies with absence of corpus luteum
Receives: Drug: Estradiol + Progesterone
NC-FET (natural cycle FET, endometrial preparation with presence of CL)Active comparatorPregnancies with presence of corpus luteum
Receives: Drug: Ovitrelle ( Hcg 250 mcg)
Control ArmNo interventionSpontaneous pregnancies with no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal: Relaxin-2 plasma concentrations.

    Measured: Up to 10 month

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

    Measured: Up to 10 month

Secondary outcomes (39)

  1. Angiogenic/vasoactive function of corpus luteum and placenta

    Measured: Up to 10 month

  2. plasma concentrations of VCAM-1 and endoglin.

    Measured: Up to 10 month

  3. Maternal endothelial function

    Measured: Up to 10 month

  4. Maternal echocardiography: cardiac output (L/min)

    Measured: Up to 10 month

  5. Fetal programming

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

    Measured: Up to 10 month

  6. Fetal programming

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

    Measured: Up to 10 month

  7. Fetal growth

    Fetal crown-rump length (CRL)(cm)

    Measured: At 12 week of gestation

  8. Fetal growth

    Biometry (mm)

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

  9. Neonatal data

    Apgar 5' test(parameter/puntuation)

    Measured: At Delivery

  10. 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

    Measured: At Delivery

  11. Preconceptional parameters

    Both parents: age(years)

    Measured: Visit 0 (Baseline)

  12. Maternal Cardivascular Function

    Plasma NT-proBNP concentration(pg/mL)

    Measured: Up to 10 month

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

    Measured: Up to 10 month

  14. Fetal programming

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

    Measured: Up to 10 month

  15. Fetal programming

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

    Measured: Up to 10 month

  16. Fetal programming

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

    Measured: Up to 10 month

  17. Fetal programming

    Isovolumetric relaxation time (IRT)(mL/mmHg)

    Measured: Up to 10 month

  18. Fetal growth

    Nuchal translucency (NT)(mm)

    Measured: At 12 week of gestation

  19. Fetal growth

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

    Measured: At 12 week of gestation

  20. Fetal growth

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

    Measured: At 12 week of gestation

  21. Fetal growth

    Biparietal diameter (BPD)(cm)

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

  22. Fetal growth

    Head circumference (HC)(cm)

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

  23. Fetal growth

    Abdominal circumference (AC)(cm)

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

  24. Fetal growth

    Femoral length (FL)(mm)

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

  25. Fetal growth

    Estimated fetal weight (g) and centile.

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

  26. Fetal growth

    Doppler study of umbilical artery (UA) middle cerebral artery (MCA) and mUt-PI (percentile)

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

  27. Fetal growth

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

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

  28. Neonatal data

    Umbilical artery pH(range)

    Measured: At Delivery

  29. Neonatal data

    Birth weight(kg)

    Measured: At Delivery

  30. Preconceptional parameters

    Both parents: ethnicity(descriptive)

    Measured: Visit 0 (Baseline)

  31. Preconceptional parameters

    Both parents: socioeconomic status(descriptive)

    Measured: Visit 0 (Baseline)

  32. Preconceptional parameters

    Both parents: education level(descriptive),

    Measured: Visit 0 (Baseline)

  33. Preconceptional parameters

    Both parents:

    BMI(cm/kg)

    Measured: Visit 0 (Baseline)

  34. Preconceptional parameters

    Both parents: chronic diseases(descriptive)

    Measured: Visit 0 (Baseline)

  35. Preconceptional parameters

    Both parents: smoking(yes/no)

    Measured: Visit 0 (Baseline)

  36. Preconceptional parameters

    Both parents: alcohol consumption(yes/No)

    Measured: Visit 0 (Baseline)

  37. Preconceptional parameters

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

    Measured: Visit 0 (Baseline)

  38. Maternal Cardivascular Function

    Systolic, diastolic and mean arterial blood pressure(mmHg)

    Measured: Up to 10 month

  39. Maternal Cardivascular Function

    Carotid artery intima-media thickness(mm)

    Measured: Up to 10 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2025
  2. Study start1 Feb 2025
  3. Primary completion20 Nov 2026 (estimated)
  4. Study completion20 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
334 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06896617
Sponsor's protocol ID
2024-513600-33-00
Other IDs
2024-513600-33-00
Acronym
LUTI
Status last verified
Feb 2025
First submitted
5 Dec 2024
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Estradiol + Progesterone and Ovitrelle ( Hcg 250 mcg) in people with Infertilities and Embryo Transfer, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura B Burunat, Graduate (0034932275400 ext. 4198, burunat@recerca.clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal: Relaxin-2 plasma concentrations. (time frame: Up to 10 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06896617.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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