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

Not Applicable

Completed

• Conditions: PCOS
• Interventions: Dietary Supplement: Astaxanthin 8 mg; Other: placebo

• Registration Number: NCT03991286
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Study Start: 2020-01-20
• Status Verified: 2020-02
• Primary Completion: 2020-11-01
• Study Completion: 2021-04-07
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

Diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	Astaxanthin 8 mg	Drug: Astaxanthin 8mg Drug: Ovulatory Agent Clomiphene Citrate
Placebo	placebo	Drug: Placebo Ovulatory Agent: Clomiphene Citrate

Primary Outcome Measures

Name	Time	Method
Serum and follicular fluid oxidative stress biomarkers levels	8 months	This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)

Secondary Outcome Measures

Name	Time	Method
Number of oocytes retrieved	Day1(from the day of oocyte retrieval to fertilization confirmation)	using polarized light microscopy
Number of mature(MII) oocyte	Day1(from the day of oocyte retrieval to fertilization confirmation)	using polarized light microscopy

Trial Locations

Locations (1)

Shariati Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of