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

Not Applicable

Terminated

• Conditions: Frozen Embryo Transfer; Pre-Eclampsia
• Interventions: Procedure: FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE

• Registration Number: NCT04092829
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-13
• Study Start: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-17
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 591

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE	FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE	After confirming ovarian rest (follicles \< 10 mm) with menstruation by vaginal ultrasound, hormone replacement therapy with oestrogens (6 mg/day of oral oestradiol valerate - Progynova® or Progyluton®- or 150 ug/48 h of oestradiol in patches - Evopad®) will be started on day 2-3 of the cycle. On day 10-15 of treatment an ultrasound scan will be performed to assess endometrial growth and ovarian rest. After confirming an endometrial thickness ≥ 7mm by vaginal ultrasound, ovaries with follicles smaller than 10 mm, blood estradiol \>100 pg/ml and serum progesterone \< 1 ng/ml, luteal phase support will begin with the administration of 400 mg of micronized vaginal progesterone every 12 hours, a total of 10 shots, prior to embryo transfer of a thawed euploid blastocyst. same day. If the level of serum progesterone on the day of transfer is less than 9.2 ng/ml, a daily injection of subcutaneous progesterone (Prolutex®) will be added on the same day.

Primary Outcome Measures

Name	Time	Method
Incidence of pre-eclampsia during pregnancy.	12 months	Presence or absence of pre-eclampsia during pregnancy

Secondary Outcome Measures

Name	Time	Method
Eclampsia during pregnancy	12 months	Presence or absence of Eclampsia 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
Bleeding during pregnancy	12 months	Presence or absence of Bleeding during pregnancy
Hypertension during pregnancy	12 months	Presence or absence of Hypertension during pregnancy
Premature detachment of normoinserted placenta during pregnancy	12 months	Presence or absence of premature detachment of normoinserted placenta during pregnancy
Preterm premature rupture of membranes during pregnancy.	12 months	Presence or absence of preterm premature rupture of membranes during pregnancy
Retarded intrauterine growth during pregnancy	12 months	Presence or absence of retarded intrauterine growth at birth
Preeclampsia during pregnancy	12 months	Presence or absence of Preeclampsia during pregnancy
Type II Diabetes during pregnancy	12 months	Presence or absence of Type II Diabetes during pregnancy
Fetal death	12 months	Presence or absence of fetal death at birth.
Help Sindrome during pregnancy	12 months	Presence or absence of Help Sindrome during pregnancy

Trial Locations

Locations (1)

Ivi Valencia; 🇪🇸 Valencia, Spain