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

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

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.

Sponsors & Collaborators

• IVI Bilbao

  collaborator OTHER

• IVI Barcelona

  collaborator OTHER

• IVI Madrid

  collaborator OTHER

• Vida Recoletas Sevilla

  collaborator OTHER

• IVI Vigo

  collaborator OTHER

• IVI Roma

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• IVI Mallorca

  collaborator NETWORK

• Instituto Valenciano de Infertilidad, IVI VALENCIA

  lead OTHER

Principal Investigators

• JOSE BELLVER PRADAS, MDPhD · IVIRMA VALENCIA

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

44 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-16

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Spain

Study Locations