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

Pre-Eclampsia Clinical Trial

— PREECLAM-2019  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04092829
• Other study ID #: 1906-VLC-067-JB
• Status: Terminated
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2024
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 591
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Frozen Embryo Transfer
• Pre-Eclampsia

Intervention

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.

Locations

Country	Name	City	State
Spain	Ivi Valencia	Valencia

Sponsors (9)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA	Hospital Universitario La Paz, IVI Barcelona, IVI Bilbao, IVI Madrid, IVI Mallorca, IVI Roma, IVI Sevilla, IVI Vigo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pre-eclampsia during pregnancy.	Presence or absence of pre-eclampsia during pregnancy	12 months
Secondary	Bleeding during pregnancy	Presence or absence of Bleeding during pregnancy	12 months
Secondary	Hypertension during pregnancy	Presence or absence of Hypertension during pregnancy	12 months
Secondary	Eclampsia during pregnancy	Presence or absence of Eclampsia during pregnancy	12 months
Secondary	Preeclampsia during pregnancy	Presence or absence of Preeclampsia during pregnancy	12 months
Secondary	Retarded intrauterine growth during pregnancy	Presence or absence of retarded intrauterine growth at birth	12 months
Secondary	Premature detachment of normoinserted placenta during pregnancy	Presence or absence of premature detachment of normoinserted placenta during pregnancy	12 months
Secondary	Type II Diabetes during pregnancy	Presence or absence of Type II Diabetes during pregnancy	12 months
Secondary	Help Sindrome during pregnancy	Presence or absence of Help Sindrome during pregnancy	12 months
Secondary	Alterations in the volume of the amniotic fluid during pregnancy	Presence or absence of alterations in the volume of the amniotic fluid during pregnancy	12 months
Secondary	Preterm premature rupture of membranes during pregnancy.	Presence or absence of preterm premature rupture of membranes during pregnancy	12 months
Secondary	Fetal death	Presence or absence of fetal death at birth.	12 months