Clinical trial NCT04092829: Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer
Official title: Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pre-Eclampsia
Frozen Embryo Transfer
Keywords: Pre-Eclampsia
Corpus Luteum
Frozen embryo transfer
Endometrial preparation
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
Collaborators: name: IVI Bilbao
name: IVI Barcelona
name: IVI Madrid
name: Vida Recoletas Sevilla
name: IVI Vigo
name: IVI Roma
name: Hospital Universitario La Paz
name: IVI Mallorca
First posted: 2019-09-17
Enrollment: 591
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized prospective analysis.
Primary purpose: DIAGNOSTIC

Brief summary: Identifying modifiable factors that contribute to preeclampsia risk associated with assisted reproduction can improve maternal health. Recent studies have shown an increased risk for hypertensive disorders of pregnancy after in vitro fertilization, particularly for pregnancies occurring during a hormone replacement therapy such a donor egg recipient and a frozen embryo transfer. This risk may be partly attributable to the degree by which the assisted reproductive treatment affects the maternal hormonal environment, when the corpus luteum is a major source of reproductive hormones. On the other hand, cryopreserved embryos are usually thawed and replaced in in a natural or hormonally manipulated cycle; on this point, frozen embryo transfer is associated with better perinatal outcome regarding preterm birth and low birth weight yet higher risk of large for gestational age and macrosomia compared to fresh transfer. The objective of our study is to investigate whether the absence of corpus luteum adversely affects pregnancy and to analyse if there are differences in the perinatal outcomes due to differences in the endometrial preparation protocol for a frozen embryo transfer.


Eligibility criteria: Inclusion criteria

* All patients who, after IVF-PGT-A treatment with their own oocytes, present a euploid embryo for transfer.
* Transfer of a single euploid embryo

Exclusion criteria:

* Moderate or high smoking (\> 5 cigarettes/day)
* BMI ≥30 kg/m2
* Chronic hypertension
* History of preeclampsia in previous pregnancies
* History of delayed uterine growth and placental insufficiency in previous pregnancies
* Use of donor sperm
* Woman's age ≥44 years
* Women with menstrual cycles longer than 35 days

Primary outcomes:
measure: Incidence of pre-eclampsia during pregnancy.
timeFrame: 12 months
Secondary outcomes:
measure: Bleeding during pregnancy
timeFrame: 12 months
measure: Hypertension during pregnancy
timeFrame: 12 months
measure: Eclampsia during pregnancy
timeFrame: 12 months
measure: Preeclampsia during pregnancy
timeFrame: 12 months
measure: Retarded intrauterine growth during pregnancy
timeFrame: 12 months
measure: Premature detachment of normoinserted placenta during pregnancy
timeFrame: 12 months
measure: Type II Diabetes during pregnancy
timeFrame: 12 months
measure: Help Sindrome during pregnancy
timeFrame: 12 months
measure: Alterations in the volume of the amniotic fluid during pregnancy
timeFrame: 12 months
measure: Preterm premature rupture of membranes during pregnancy.
timeFrame: 12 months
measure: Fetal death
timeFrame: 12 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ivi Valencia
Study officials:
affiliation: IVIRMA VALENCIA
name: JOSE BELLVER PRADAS, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: