Intravascular Laser Irradiation of Blood Use in Poor Ovarian Responders

Study Overview
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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.

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

Conditions
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Unrecognized Condition

Intervention / Treatment
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* Other: Intravascular laser irradiation of blood


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients received intravascular laser irradiation of blood for 20 days before IVF cycles | Other: Intravascular laser irradiation of blood<br>* Intravascular laser irradiation of blood via an intravenous catheter for irradiation of the blood under a period of 60 minutes daily for 20 days<br>|
| No Intervention: Control<br>No intervention before IVF cycles | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mitochondrial function of cumulus cells | Oxygen consumption and adenosine triphosphate production | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravascular laser irradiation of blood, He-Ne laser, Poor ovarian responder, Assisted reproductive technology, In vitro fertilization, Anti-aging