NCT04092829

Impact of Corpus Luteum Presence or Absence in the Incidence of Preeclampsia After Frozen Embryo Transfer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 591 (actual)
• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pre-Eclampsia
• Frozen Embryo Transfer

Interventions

Type	Name	Description
PROCEDURE	FROZEN 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.

Timeline

• Start date: 2019-09-16
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-09-17
• Last updated: 2024-03-22

Locations

1 site across 1 country: Spain