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

NCT ID: NCT06896617

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-12-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PC-FET (endometrial preparation with absence of CL)

Pregnancies with absence of corpus luteum

Group Type: ACTIVE_COMPARATOR

Estradiol + Progesterone

Intervention Type: DRUG

Pregnancies with absence of corpus luteum(PC-FET)

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

Pregnancies with presence of corpus luteum

Group Type: ACTIVE_COMPARATOR

Ovitrelle ( Hcg 250 mcg)

Intervention Type: DRUG

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

Control Arm

Spontaneous pregnancies with no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Estradiol + Progesterone

Pregnancies with absence of corpus luteum(PC-FET)

Intervention Type: DRUG

Ovitrelle ( Hcg 250 mcg)

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Laura Burunat

Barcelona, Spain, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Laura B Burunat, Graduate

Role: CONTACT

burunat@recerca.clinic.cat

0034932275400 ext. 4198

Facility Contacts

Laura Burunat Ruesgas, Chemistry

Role: primary

burunat@recerca.clinic.cat

0034932275400 ext. 4198

Other Identifiers

2024-513600-33-00

Identifier Type: CTIS

Identifier Source: secondary_id

2024-513600-33-00

Identifier Type: -

Identifier Source: org_study_id