Effects of Corpus Luteum on Frozen Embryo Transfer Pregnancies
Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET): a Prospective Randomized Controlled Study
This study is testing how the corpus luteum affects pregnancies from frozen embryo transfers to see if it influences things like heart health and fetal growth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 334 (estimated) |
| Ages | 18 Years to 41 Years |
| Sex | Female |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica Academic / other |
| Locations | 1 site (Barcelona, Spain) |
| Trial ID | NCT06896617 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of the corpus luteum on pregnancies achieved through programmed frozen embryo transfer (PC-FET) and modified natural frozen embryo transfer (mNC-FET). It aims to assess differences in endothelial and placental function, maternal cardiovascular function, fetal growth, and fetal cardiovascular and cerebral programming. The study will also explore the relationship between these differences and the plasma concentrations of key secretion products from the corpus luteum that have vasoactive and angiogenic properties.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-37 with regular menstrual cycles and available cryopreserved blastocysts for single embryo transfer.
Not a fit: Patients with recurrent pregnancy loss, recurrent implantation failure, or certain medical conditions such as polycystic ovarian syndrome or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how the corpus luteum affects pregnancy outcomes, potentially leading to improved fertility treatments.
How similar studies have performed: While there is limited information on similar studies, the investigation of the corpus luteum's role in pregnancy outcomes is a relevant area of research that has shown promise in related contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona, Spain
- Laura Burunat — Barcelona, Spain, Spain (Recruiting)
Study contacts
- Study coordinator: Laura B Burunat, Graduate
- Email: burunat@recerca.clinic.cat
- Phone: 0034932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.