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

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Enrolling; Phase 4

Conditions: Embryo Transfer; Infertilities

Treatments: Drug: Ovitrelle ( Hcg 250 mcg); Drug: Estradiol + Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT06896617

2024-513600-33-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 334 estimated patients

Sex: Female

Ages: 18 to 41 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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334 participants in 3 patient groups

PC-FET (endometrial preparation with absence of CL)

Active Comparator group

Description:

Pregnancies with absence of corpus luteum

Treatment:

Drug: Estradiol + Progesterone

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

Active Comparator group

Description:

Pregnancies with presence of corpus luteum

Treatment:

Drug: Ovitrelle ( Hcg 250 mcg)

Control Arm

No Intervention group

Description:

Spontaneous pregnancies with no intervention