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NCT Number: NCT06896617

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

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.

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Key information

Conditions

Infertilities Embryo Transfer

Age range

18 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Laura Burunat

Barcelona, Spain, 08036

Location status: Recruiting

Location contact

Laura Burunat Ruesgas, Chemistry

CONTACT

[email protected]

0034932275400 ext. 4198

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Estradiol + Progesterone

Drug

Pregnancies with absence of corpus luteum(PC-FET)

Ovitrelle ( Hcg 250 mcg)

Drug

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

Primary outcomes

  1. Maternal: Relaxin-2 plasma concentrations.

    Time frame: Up to 10 month

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

    Time frame: Up to 10 month

Secondary outcomes

  1. Angiogenic/vasoactive function of corpus luteum and placenta

    Time frame: Up to 10 month

  2. plasma concentrations of VCAM-1 and endoglin.

    Time frame: Up to 10 month

  3. Maternal endothelial function

    Time frame: Up to 10 month

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

    Time frame: Up to 10 month

  5. Fetal programming

    Time frame: Up to 10 month

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

  6. Fetal programming

    Time frame: Up to 10 month

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

  7. Fetal growth

    Time frame: At 12 week of gestation

    Fetal crown-rump length (CRL)(cm)

  8. Fetal growth

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

    Biometry (mm)

  9. Neonatal data

    Time frame: At Delivery

    Apgar 5' test(parameter/puntuation)

  10. 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

  11. Preconceptional parameters

    Time frame: Visit 0 (Baseline)

    Both parents: age(years)

  12. Maternal Cardivascular Function

    Time frame: Up to 10 month

    Plasma NT-proBNP concentration(pg/mL)

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

    Time frame: Up to 10 month

  14. Fetal programming

    Time frame: Up to 10 month

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

  15. Fetal programming

    Time frame: Up to 10 month

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

  16. Fetal programming

    Time frame: Up to 10 month

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

  17. Fetal programming

    Time frame: Up to 10 month

    Isovolumetric relaxation time (IRT)(mL/mmHg)

  18. Fetal growth

    Time frame: At 12 week of gestation

    Nuchal translucency (NT)(mm)

  19. Fetal growth

    Time frame: At 12 week of gestation

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

  20. Fetal growth

    Time frame: At 12 week of gestation

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

  21. Fetal growth

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

    Biparietal diameter (BPD)(cm)

  22. Fetal growth

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

    Head circumference (HC)(cm)

  23. Fetal growth

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

    Abdominal circumference (AC)(cm)

  24. Fetal growth

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

    Femoral length (FL)(mm)

  25. Fetal growth

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

    Estimated fetal weight (g) and centile.

  26. 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)

  27. Fetal growth

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

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

  28. Neonatal data

    Time frame: At Delivery

    Umbilical artery pH(range)

  29. Neonatal data

    Time frame: At Delivery

    Birth weight(kg)

  30. Preconceptional parameters

    Time frame: Visit 0 (Baseline)

    Both parents: ethnicity(descriptive)

  31. Preconceptional parameters

    Time frame: Visit 0 (Baseline)

    Both parents: socioeconomic status(descriptive)

  32. Preconceptional parameters

    Time frame: Visit 0 (Baseline)

    Both parents: education level(descriptive),

  33. Preconceptional parameters

    Time frame: Visit 0 (Baseline)

    Both parents:

    BMI(cm/kg)

  34. Preconceptional parameters

    Time frame: Visit 0 (Baseline)

    Both parents: chronic diseases(descriptive)

  35. Preconceptional parameters

    Time frame: Visit 0 (Baseline)

    Both parents: smoking(yes/no)

  36. Preconceptional parameters

    Time frame: Visit 0 (Baseline)

    Both parents: alcohol consumption(yes/No)

  37. Preconceptional parameters

    Time frame: Visit 0 (Baseline)

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

  38. Maternal Cardivascular Function

    Time frame: Up to 10 month

    Systolic, diastolic and mean arterial blood pressure(mmHg)

  39. Maternal Cardivascular Function

    Time frame: Up to 10 month

    Carotid artery intima-media thickness(mm)

Study contacts

Contact information is provided by the study sponsor or research team.

Laura B Burunat, Graduate

CONTACT

[email protected]

0034932275400 ext. 4198

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Official study title

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

Acronym: LUTI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 26, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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