Frozen Embryo Transfer, Pre-Eclampsia
Conditions
Keywords
Pre-Eclampsia, Corpus Luteum, Frozen embryo transfer, Endometrial preparation
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.
Interventions
PROCEDUREFROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE
The intervention group will be prepared with hormone replacement therapy with estrogens according to usual clinical practice. Frozen embryos will be transferred after ten doses of exogenous progesterone.
Sponsors
IVI Bilbao
IVI Barcelona
IVI Madrid
Vida Recoletas Sevilla
IVI Vigo
IVI Roma
Hospital Universitario La Paz
IVI Mallorca
Instituto Valenciano de Infertilidad, IVI VALENCIA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Randomized prospective analysis.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pre-eclampsia during pregnancy. | 12 months | Presence or absence of pre-eclampsia during pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypertension during pregnancy | 12 months | Presence or absence of Hypertension during pregnancy |
| Eclampsia during pregnancy | 12 months | Presence or absence of Eclampsia during pregnancy |
| Preeclampsia during pregnancy | 12 months | Presence or absence of Preeclampsia during pregnancy |
| Retarded intrauterine growth during pregnancy | 12 months | Presence or absence of retarded intrauterine growth at birth |
| Premature detachment of normoinserted placenta during pregnancy | 12 months | Presence or absence of premature detachment of normoinserted placenta during pregnancy |
| Bleeding during pregnancy | 12 months | Presence or absence of Bleeding during pregnancy |
| Help Sindrome during pregnancy | 12 months | Presence or absence of Help Sindrome during pregnancy |
| Alterations in the volume of the amniotic fluid during pregnancy | 12 months | Presence or absence of alterations in the volume of the amniotic fluid during pregnancy |
| Preterm premature rupture of membranes during pregnancy. | 12 months | Presence or absence of preterm premature rupture of membranes during pregnancy |
| Fetal death | 12 months | Presence or absence of fetal death at birth. |
| Type II Diabetes during pregnancy | 12 months | Presence or absence of Type II Diabetes during pregnancy |
Countries
Spain
Outcome results
None listed