Laser Clinical Trial
Official title:
Effects of Intravenous Laser Irradiation on Treatment Resistant Thin Endometrium in Women Undergoing Frozen Thawed Embryo Transfer Cycles
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.
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.
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