跳至主要内容
临床试验/NCT03081130
NCT03081130Unknown不适用

Effects of Intravenous Laser Irradiation on Treatment Resistant Thin Endometrium in Women Undergoing Frozen Thawed Embryo Transfer Cycles

Kaohsiung Veterans General Hospital.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Endometrium thickness

研究概览

简要总结

We will recruit 30 poor ovarian responders and thin endometrium patients, aged 35-45 year old, and treat with intravascular laser irradiation of blood (ILIB) via an intravenous catheter for irradiation of the blood under a period of 60 minutes for 10 days. We will evaluate the number and the quality of oocyte retrieved, endometrium thickness and pregnancy rate. The goal of the study is to evaluate whether ILIB is the efficient treatment to improve the ovarian response and the clinical outcome of the poor ovarian responders and thin endometrium patients.

详细描述

Intravenous laser irradiation of blood (ILIB) is the use of He-Ne laser (632.8 nm) via an intravenous catheter for irradiation of the blood with a lower power of 1-5 milliwatt (mW) and a period of 10-90 minutes to promote functional re-generation mitochondria and pro-oxidant/antioxidant equilibrium in living bodies. ILIB was developed experimentally by the Russian researchers and was introduced into clinical practice in 1981. The treatment with He-Ne laser 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. The aid of treatment of acute cerebral infarction, rheumatoid arthritis, arthrosclerosis of the leg, redifferentiation therapy of malignant tumors has been studies for years and over the past 30 years, there are growing studies that has challenging the therapeutic effect of ILIB.

The incidence of poor ovarian responders and thin endometrium patients among infertile women has been estimated at 9-24%. It fact, as a result of a lower number of oocytes retrieved, there are fewer embryos to select and transfer and subsequently these patients have lower pregnancy rates per transfer and lower cumulative pregnancy rates. Despite an enormous number of papers on the topic of poor ovarian response and thin endometrium patients have been published in the literature, so far it has been impossible to identify any efficient treatment to improve the ovarian response and the clinical outcome of this group of patients. In most cases the mechanism involved in follicular depletion is still not clear. Previous studies showed that treatment with anti-oxidants could improve the outcomes of the poor ovarian responders and thin endometrium patients, however, the effect is limited. Since ILIB has anti-aging, anti-oxidant and anti-inflammatory effects, we want to know the effect on the poor ovarian responders and thin endometrium women. Through the lower power of He-Ne laser to promote functional re-generation mitochondria and pro-oxidant/antioxidant equilibrium, poor ovarian responders and thin endometrium women may gain the power to improve the ovarian function and endometrium function and higher the pregnancy rates.

We will recruit 30 poor ovarian responders and thin endometrium patients and treat with intravenous laser irradiation of blood (ILIB) via an intravenous catheter for irradiation of the blood under a period of 60 minutes for 10 days. We will evaluate the number and the quality of oocyte retrieved, endometrium thickness and pregnancy rate. The goal of the study is to evaluate whether ILIB is the efficient treatment to improve the ovarian response and the clinical outcome of the poor ovarian responders and thin endometrium patients.

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
— 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • We will recruit 30 poor ovarian responders and thin endometrium patients

排除标准

  • women with underlying medical diseases, such as diabetes or hypertension

结局指标

主要结局

Endometrium thickness

时间窗: after intervention 1 month and treated with estradiol

endometrium thickness evaluated by transvaginal sonography after intervention

次要结局

  • pregnancy(4 weeks after embryo transfer)

研究者

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

Hsiao-Wen Tsai

Dr. Hsiao-Wen Tsai

Kaohsiung Veterans General Hospital.

研究点 (1)

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