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

Tehran University of Medical Sciences

Status: Completed

Conditions: PCOS

Treatments: Dietary Supplement: Astaxanthin 8 mg; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03991286

98-01-30-41687

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Drug: Placebo Ovulatory Agent: Clomiphene Citrate

Treatment:

Other: placebo

experimental

Experimental group

Description:

Drug: Astaxanthin 8mg Drug: Ovulatory Agent Clomiphene Citrate

Treatment:

Dietary Supplement: Astaxanthin 8 mg