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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-41
SponsorFundacion Clinic per a la Recerca Biomédica

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 .

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

334 Participants
are divided into 3 treatment groups
Group A: PC-FET (endometrial preparation with absence of CL)Active comparator 1 intervention
Group B: NC-FET (natural cycle FET, endometrial preparation with presence of CL)Active comparator 1 intervention
Group C: Control ArmNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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