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临床试验/NCT05661539
NCT05661539招募中不适用

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

Akdeniz University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Live Birth Rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Live Birth Rate

时间窗: 9 months

pregnancy beyond 24 weeks of gestational age.

Obstetric Complication Rates

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ŞAFAK OLGAN

Associate Professor

Akdeniz University

研究点 (1)

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