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Clinical Trials/NCT05661539
NCT05661539
Recruiting
Not Applicable

The Effect of Baseline and First Trimester Uterine Artery Doppler Velocimetry Parameters on Obstetric Outcomes in HRT-FET Cycles: Prospective Cohort Study

Akdeniz University1 site in 1 country500 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Female
Sponsor
Akdeniz University
Enrollment
500
Locations
1
Primary Endpoint
Live Birth Rate
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The researchers aim to determine how baseline (preconceptional) and first-trimester uterine artery Doppler measurements affect obstetric complications in women undergoing high-quality blastocyst transfer and to determine the correlation between the two Doppler measurements.

Detailed Description

Only patients with high-quality blastocyst-stage embryos will be included in the study. In frozen embryo transfer cycles prepared hormonally, basal bilateral uterine artery Doppler velocimetry will be performed before treatment (preconception) in each patient. Bilateral uterine artery Doppler velocimetry will be performed during the basal ultrasonography (2-5 days of menstruation). The absence of any uterine artery notches, diastolic or reverse flow will also be noted. In addition, sub-endometrial (arcuate artery) blood flows will be evaluated by Doppler ultrasonography. For endometrial preparation, estrogen replacement will be given for approximately 12-14 days as a routine In cases with endometrial thickness ≥7mm, progesterone treatment will be started and embryo transfer will be planned on the 6th day of the treatment. In the pregnant group, measurements will be repeated at the end of the first trimester (11-14 weeks) and uterine artery Doppler velocimetry will be reevaluated. In addition, patients will be followed up until delivery and possible obstetric complications will be recorded. Baseline and first-trimester uterine artery Doppler ultrasonography findings will be compared with obstetric results. Obstetric outcomes such as birth weight at the end of pregnancy, small-large for gestational age, presence of hypertension, and preterm delivery will be correlated with preconceptional and first-trimester uterine artery Doppler parameters.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
April 15, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ŞAFAK OLGAN

Associate Professor

Akdeniz University

Eligibility Criteria

Inclusion Criteria

  • Exogenous hormone preparation of the endometrial lining
  • High embryo quality ((≥2BB) according to Alpha criteria
  • Embryo transfer at the blastocyst stage

Exclusion Criteria

  • Patients whose treatments were canceled for any reason before the embryo transfer procedure
  • Patients who underwent embryo transfer in the cleavage stage
  • Presence of low-quality (\<2BB) blastocysts
  • \>15% loss of viability of the embryo during embryo thawing,
  • Patients with congenital uterine malformations,
  • Patients in whom Doppler velocimetry cannot be performed optimally

Outcomes

Primary Outcomes

Live Birth Rate

Time Frame: 9 months

pregnancy beyond 24 weeks of gestational age.

Obstetric Complication Rates

Time Frame: 20 weeks after embryo transfer

Conditions such as preeclampsia, eclampsia, fetal growth restriction, oligohydramnios, polyhydramnios, preterm birth, gestational diabetes mellitus, antenatal bleeding and etc. that develop during pregnancy

Study Sites (1)

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