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Intravenous Laser Irradiation Effect on Treatment Resistant Thin Endometrium

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03081130
Enrollment
60
Registered
2017-03-16
Start date
2017-02-01
Completion date
2018-03-31
Last updated
2017-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrium, Laser

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREIntravenous laser irradiation treatment

control group

Sponsors

Kaohsiung Veterans General Hospital.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Endometrium thicknessafter intervention 1 month and treated with estradiolendometrium thickness evaluated by transvaginal sonography after intervention

Secondary

MeasureTime frameDescription
pregnancy4 weeks after embryo transferpregnancy

Countries

Taiwan

Contacts

Primary ContactHsiao-Wen Tsai
drtsai0627@gmail.com886-7-3422121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026