Intravascular Laser Irradiation of Blood Use in Poor Ovarian Responders

NCT ID: NCT05873075

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-27

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Unrecognized Condition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

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

Group Type EXPERIMENTAL

Intravascular laser irradiation of blood

Intervention Type 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

Control

No intervention before IVF cycles

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Li-Te Lin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuan-Hao Tsui

Role: STUDY_DIRECTOR

Kaohsiung Veterans General Hospital.

Locations

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

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 25699161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25941421 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22891782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31928249 (View on PubMed)

Other Identifiers

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KSVGH23-CT3-20

Identifier Type: -

Identifier Source: org_study_id

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