Intravascular Laser Irradiation of Blood Use in Poor Ovarian Responders

• Sponsor: Kaohsiung Veterans General Hospital. (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05873075
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Unrecognized Condition	Other: Intravascular laser irradiation of blood	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effects of Intravascular Laser Irradiation of Blood on Reproductive Outcomes in Poor Ovaria n Responders Undergoing in Vitro Fertilization Cycles
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study group Patients received intravascular laser irradiation of blood for 20 days before IVF cycles	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
No Intervention: Control No intervention before IVF cycles

Outcome Measures

Primary Outcome Measures

1. Ongoing pregnancy rate [through study completion, an average of 1 year]

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

2. Ovarian reserve marker [through study completion, an average of 1 year]

   Anti-mullerian hormone levels

Secondary Outcome Measures

1. mitochondrial function of cumulus cells [through study completion, an average of 1 year]

   Oxygen consumption and adenosine triphosphate production

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan	Kaohsiung		Taiwan	886

Sponsors and Collaborators

• Kaohsiung Veterans General Hospital.

Investigators

• Study Director: Kuan-Hao Tsui, Kaohsiung Veterans General Hospital.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Li-Te Lin, Principal Investigator, Kaohsiung Veterans General Hospital.
• ClinicalTrials.gov Identifier: NCT05873075
• Other Study ID Numbers: KSVGH23-CT3-20
• First Posted: May 24, 2023
• Last Update Posted: May 26, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Li-Te Lin, Principal Investigator, Kaohsiung Veterans General Hospital.: Intravascular laser irradiation of blood; He-Ne laser; Poor ovarian responder; Assisted reproductive technology; In vitro fertilization; Anti-aging

Study Results

No Results Posted as of May 26, 2023