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临床试验/NCT05526014
NCT05526014招募中不适用

The Effect of Baseline Bilateral Uterine Artery Doppler Velocimetry on Obstetric Outcomes in Hormonally Prepared Vitrified-Warmed Blastocyst Transfer Cycles: a 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5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

Researchers aim to determine how baseline (pre-conceptional) uterine perfusion characteristics affect implantation rates and obstetric complications in women who underwent high-quality blastocyst transfer.

详细描述

In hormonally prepared frozen embryo transfer cycles, basal bilateral uterine artery Doppler velocimetry will be performed before treatment (pre-conceptional) in each patient. Only patients who have high-quality blastocyst stage embryos will be included in the study. Since the implantation potential of the specified embryos is high, possible embryo-induced implantation failure would be minimized.

Bilateral uterine artery Doppler velocimetry will be performed during the basal ultrasonography (on the 2-5th day of menstruation). Any uterine artery notch, absent diastolic or reverse flow also will be recorded. 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.

A pregnancy test will be performed 9 days after embryo transfer. Pregnant patients will be called for ultrasonography control 3 weeks later to determine fetal heartbeat. Additionally, the patients will be followed till labor and any obstetric complications will be recorded.

Uterine artery Doppler ultrasonography findings in patients with and without pregnancy will be compared. Additionally, in the group in which pregnancy was achieved, obstetric results including birth weight, small-large for gestational age, presence of hypertension, and preterm labor will be correlated with baseline (pre-conceptional) 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: 24th gestational weeks till delivery

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

  • Positive β-hCG results(Nine days after each embryo transfer)

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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