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

PCOS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991286
• Other study ID #: 98-01-30-41687
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: April 7, 2021

Study information

• Verified date: February 2020
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 7, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• PCOS
• Polycystic Ovary Syndrome

Intervention

Dietary Supplement:
• Astaxanthin 8 mg
experimental

Other:
• placebo
Matching placebo pill

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shariati Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum and follicular fluid oxidative stress biomarkers levels	This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)	8 months
Secondary	Number of oocytes retrieved	using polarized light microscopy	Day1(from the day of oocyte retrieval to fertilization confirmation)
Secondary	Number of mature(MII) oocyte	using polarized light microscopy	Day1(from the day of oocyte retrieval to fertilization confirmation)