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临床试验/NCT04247204
NCT04247204Unknown不适用

3D Power Doppler Ultrasound Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen-thawed Embryo Transfer Cycles: a Pilot Study.

Hatem AbuHashim0 个研究点目标入组 30 人开始时间: 2020年2月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Vascularization index of the endometrial region

研究概览

简要总结

A good quality embryo and receptive endometrium are important aspects in achieving optimal outcomes in assisted reproductive treatment (ART). Endometrial thickness is an important marker of uterine receptivity. A thin endometrium defined by an endometrial thickness ≤7mm was reported as a poor factor associated with significantly lower implantation and pregnancy rates as well as a higher risk of miscarriage.

Nowadays, platelet-rich plasma (PRP) intrauterine infusion is a promising approach for the treatment of refractory thin endometrium in patients undergoing frozen-thawed embryo transfer. This is based on its ability to stimulate proliferation and angiogenesis with a large number of growth factors and cytokines i.e. the endometrium becomes thicker, with higher vascularity. PRP is easily prepared from an autologous blood sample that eliminates the risk of immunological reactions and transmission infections at low cost.

Endometrial blood flow is another important marker reflective of uterine receptivity. Although publications are increasing concerning the efficacy of PRP intrauterine infusion on endometrial expansion and proliferation in frozen-thawed embryo transfer cycles, yet its angiogenetic effects have not been evaluated so far in either thin endometrium or normal endometrium thickness.

Our study aims to evaluate endometrial and sub-endometrial vasculature patterns before and after PRP infusion in frozen-thawed embryo transfer cycles with normal endometrium thickness.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Subfertile women undergoing frozen-thawed embryo transfer with at least previously failed one ICSI cycle.
  • Age between 20-35 years.
  • Women with endometrium thickness between 8-14 mm on D15 of the frozen embryo transfer cycle

排除标准

  • Women with a thin endometrium (≤ 7 mm) on day 15 of the cycle.
  • Women with known hematological or immunological disorders
  • Women with uncontrolled endocrine or other medical conditions, such as hyperprolactinemia or thyroid diseases.
  • Women with uterine abnormalities e.g. Asherman syndrome, myomas, uterine septum, bicornuate uterus.
  • Women who refuse to participate in the study.

结局指标

主要结局

Vascularization index of the endometrial region

时间窗: Day 15 to 18 of the frozen embryo transfer cycle

Vascularization index of the endometrial region will be measured by a researcher using the built-in VOCAL (Virtual Organ Computer-Aided Analysis) software for 3D power Doppler analysis.

次要结局

  • Vascularization flow index of the endometrial region(Day 15 to 18 of the frozen embryo transfer cycle)
  • Vascularization index of the sub-endometrial region(Day 15 to 18 of the frozen embryo transfer cycle)
  • Flow index of the endometrial region(Day 15 to 18 of the frozen embryo transfer cycle)
  • Flow index of the sub-endometrial region(Day 15 to 18 of the frozen embryo transfer cycle)
  • Vascularization flow index of the sub-endometrial region(Day 15 to 18 of the frozen embryo transfer cycle)

研究者

发起方
Hatem AbuHashim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hatem AbuHashim

Professor

Mansoura University

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