The Effect of Astaxanthin on Oxidative Stress Indices in Patients With Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age It is hypothesized that ∼20 fold increase in reactive oxygen species (ROS) generation in Follicular fluid (FF) and granulosa cells of PCOS women plays an adverse role in affecting the IVF success rate. Astaxanthin (3,3'-dihydroxy-β,β'-carotene-4,4'-dione) is a nonprovitamin A carotenoid classified as a xanthophyll and is found in high amounts in the red pigment of crustacean shells (e.g., crabs, shrimp), salmon, trout, and asteroides. It has been demonstrated that astaxanthin displays a wide variety of biological activities, including anti-oxidative, anticancer, and anti-inflammatory effects. investigators aim to investigate the effect on Astaxanthin administrating on reducing of ROS in FF and induction of antioxidant response elements in PCOS women.

Official Title
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The Effect of Astaxanthin on Oxidative Stress Indices in Serum, and Induction of Signaling Pathways in Granulosa Cells in Patients With Polycystic Ovary Syndrome

Conditions
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PCOS

Intervention / Treatment
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* Dietary Supplement: Astaxanthin 8 mg
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria Exclusion Criteria: Menopause, pregnant or lactating females individuals with diabetes those with hepatic,renal, thyroid or cardiovascular disorders patients with elevated levels of prolactin those who were taking antioxidant supplements within the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Drug: Placebo Ovulatory Agent: Clomiphene Citrate | Other: placebo<br>* Matching placebo pill<br>|
| Experimental: experimental<br>Drug: Astaxanthin 8mg Drug: Ovulatory Agent Clomiphene Citrate | Dietary Supplement: Astaxanthin 8 mg<br>* experimental<br>* Other names: Algalife, Icelandic Astaxanthin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum and follicular fluid oxidative stress biomarkers levels | This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs) | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved | using polarized light microscopy | Day1(from the day of oocyte retrieval to fertilization confirmation) | 
| Number of mature(MII) oocyte | using polarized light microscopy | Day1(from the day of oocyte retrieval to fertilization confirmation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, Astaxanthin, ROS