Intravascular Laser Irradiation of Blood Use in Poor Ovarian Responders

Unrecognized Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873075
• Other study ID #: KSVGH23-CT3-20
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: Li-Te Lin
• Phone: +88673464027
• Email: litelin1982[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 44 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Unrecognized Condition

Intervention

Other:
• Intravascular laser irradiation of blood
Intravascular laser irradiation of blood via an intravenous catheter for irradiation of the blood under a period of 60 minutes daily for 20 days

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Huang SF, Tsai YA, Wu SB, Wei YH, Tsai PY, Chuang TY. Effects of intravascular laser irradiation of blood in mitochondria dysfunction and oxidative stress in adults with chronic spinal cord injury. Photomed Laser Surg. 2012 Oct;30(10):579-86. doi: 10.1089/pho.2012.3228. Epub 2012 Aug 14. — View Citation

Mikhaylov VA. The use of Intravenous Laser Blood Irradiation (ILBI) at 630-640 nm to prevent vascular diseases and to increase life expectancy. Laser Ther. 2015 Mar 31;24(1):15-26. doi: 10.5978/islsm.15-OR-02. — View Citation

Momenzadeh S, Abbasi M, Ebadifar A, Aryani M, Bayrami J, Nematollahi F. The intravenous laser blood irradiation in chronic pain and fibromyalgia. J Lasers Med Sci. 2015 Winter;6(1):6-9. — View Citation

Tsai HW, Wang PH, Hsu PT, Chen SN, Lin LT, Li CJ, Tsui KH. Laser irradiation pretreatment improves endometrial preparation of frozen-thawed embryo transfer in recurrent implantation failure patients. Gynecol Endocrinol. 2020 Aug;36(8):734-738. doi: 10.1080/09513590.2020.1712694. Epub 2020 Jan 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	continuous presence of a fetal heartbeat over 12 weeks of a pregnancy	through study completion, an average of 1 year
Primary	Ovarian reserve marker	Anti-mullerian hormone levels	through study completion, an average of 1 year
Secondary	mitochondrial function of cumulus cells	Oxygen consumption and adenosine triphosphate production	through study completion, an average of 1 year