Actively Recruiting

Phase 4
Age: 18Years - 41Years
FEMALE
Healthy Volunteers
ID06896617

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

Led by Fundacion Clinic per a la Recerca Biomédica · Updated on 2025-04-02

334

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying pregnancies achieved through programmed frozen embryo transfer cycles (PC-FET) and modified natural frozen embryo transfer (mNC-FET) to see if there are differences in how the placenta and blood vessels function, as well as how the mother's heart and the baby's growth and brain development are affected. They are particularly interested in how these differences relate to substances produced by the Corpus Luteum, which play roles in blood vessel and tissue growth. This study is a prospective randomized controlled trial sponsored by Fundacion Clinic per a la Recerca Biome9dica. The trial compares three groups: pregnancies without the Corpus Luteum using estradiol and progesterone (PC-FET), pregnancies with the Corpus Luteum using Ovitrelle (Hcg 250 mcg) (NC-FET), and spontaneous pregnancies with no intervention as a control. Participants are randomly assigned to one of these groups. Treatments involve hormone support or natural cycle preparation depending on the group. The study follows participants up to 10 months, with assessments at various points including delivery. Participants undergo multiple evaluations including blood tests to measure hormone levels like Relaxin-2, heart ultrasounds to examine fetal heart function (MAPSE), and tracking of fetal growth at 12, 20, 28, 32, and 36 weeks of pregnancy. Data on the placenta and newborn are collected at delivery. Maternal cardiovascular health is monitored through echocardiography and endothelial function tests. The study also collects baseline preconception parameters. Overall, the involvement spans from before embryo transfer through pregnancy and up to 10 months, with detailed monitoring of mother and baby health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 41Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 37 at oocyte retrieval and less than 41 years at embryo transfer
  • Regular menstrual cycles between 24 and 35 days
  • Availability of cryopreserved blastocysts from own gametes
  • Indication for single embryo transfer
  • Candidates for either of the two procedures under study with no contraindications
Not Eligible

You will not qualify if you...

  • History of three or more pregnancy losses
  • Three or more unsuccessful embryo transfers in previous IVF treatments
  • Diagnosis of polycystic ovarian syndrome, diabetes mellitus, chronic arterial hypertension, maternal heart disease, or autoimmune diseases such as Systemic Lupus Erythematosus or Antiphospholipid syndrome
  • Current treatment with aspirin, heparin, anticoagulants, antihypertensives, or other drugs for circulation or coagulation disorders
  • Indication for Preimplantation Genetic Testing
  • Multiple pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to embryo transfer

Participants receive endometrial preparation through either estradiol and progesterone or natural cycle triggering with Ovitrelle (Hcg 250 mcg) before embryo transfer.

1 baseline visit and several visits during endometrial preparation

Long-term Monitoring

Duration - Up to 10 months

Participants are monitored during pregnancy and up to 10 months post-transfer to assess maternal and fetal health outcomes.

Visits at 12, 20, 28, 32, and 36 weeks of gestation, at delivery, and follow-up visits up to 10 months post-transfer

Trial Site Locations

Total: 1 location

1

Laura Burunat

Barcelona, Spain, Spain, 08036

Actively Recruiting

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Research Team

L

Laura B Burunat, Graduate

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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