Intravascular Laser Irradiation of Blood Use in Poor Ovarian Responders

NCT05873075 | Active Not Recruiting

• 1 other identifier: KSVGH23-CT3-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Unrecognized Condition

Keywords

Intravascular laser irradiation of blood; He-Ne laser; Poor ovarian responder; Assisted reproductive technology; In vitro fertilization; Anti-aging

Outcome Measures

Primary Outcomes (2)

• Ongoing pregnancy rate

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

  through study completion, an average of 1 year

• Ovarian reserve marker

  Anti-mullerian hormone levels

  through study completion, an average of 1 year

Secondary Outcomes (1)

• mitochondrial function of cumulus cells

  through study completion, an average of 1 year

Study Arms (2)

Study group

EXPERIMENTAL

Patients received intravascular laser irradiation of blood for 20 days before IVF cycles

Other: Intravascular laser irradiation of blood

Control

NO INTERVENTION

No intervention before IVF cycles

Interventions

Intravascular laser irradiation of blood OTHER

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

Study group

Eligibility Criteria

• Age: 30 Years - 44 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Kaohsiung City, 886, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 25699161 BACKGROUND

• 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.

  PMID: 25941421 BACKGROUND

• 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.

  PMID: 22891782 BACKGROUND

• 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.

  PMID: 31928249 BACKGROUND

Study Officials

• Kuan-Hao Tsui

  Kaohsiung Veterans General Hospital.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 24, 2023
• Study Start: April 27, 2023
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)