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临床试验/NCT05873075
NCT05873075进行中(未招募)不适用

The Effects of Intravascular Laser Irradiation of Blood on Reproductive Outcomes in Poor Ovaria n Responders Undergoing in Vitro Fertilization Cycles

Kaohsiung Veterans General Hospital.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Ovarian reserve marker

研究概览

简要总结

The aim of this study was to investigate the effects of intravascular laser irradiation of blood on outcomes of in vitro fertilization cycles in poor ovarian responders.

详细描述

Intravascular laser irradiation of blood (ILIB) with He-Ne laser (632.8nm) has been applied on many organs and on the hematologic and immunologic system. Quite a number of both animal and human experiments have demonstrated that ILIB has a wide range of effects, including biostimulation, analgesia, antiallergic effects, immunomodulation, vasodilatation, antihypoxic, anti-oxidant, anti-aging and anti-inflammatory effects.

Poor ovarian responders (PORs) defined as poor or no response to ovarian stimulation had poor prognosis in assisted artificial technique (ART), which is a great challenge in in vitro fertilization (IVF) cycles. Previous studies showed that treatment with anti-oxidants could improve the outcomes of the poor ovarian responders; however, the effect is limited. Since ILIB has anti-aging, anti-oxidant and anti-inflammatory effects, the investigators hypothesize that ILIB may improve ovarian function and oocyte quality in PORs. Therefore, the investigators attempt to explore the effects of ILIB on the IVF outcomes in women with poor ovarian response.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who undergoes IVF cycles
  • BMI:18-30 kg/m2
  • Diminished ovarian reserve (AFC<5, AMH<1.2 ng/ml)

排除标准

  • Primary ovarian insufficiency
  • Congenital uterine anomaly
  • Severe intrauterine adhesion
  • Severe male factor (azoospermia)
  • Chromosome anomaly
  • Malignancy
  • Donor cycles

结局指标

主要结局

Ovarian reserve marker

时间窗: through study completion, an average of 1 year

Anti-mullerian hormone levels

Ongoing pregnancy rate

时间窗: through study completion, an average of 1 year

continuous presence of a fetal heartbeat over 12 weeks of a pregnancy

次要结局

  • mitochondrial function of cumulus cells(through study completion, an average of 1 year)

研究者

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

Li-Te Lin

Principal Investigator

Kaohsiung Veterans General Hospital.

研究点 (2)

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