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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03991286

Enrollment

Registered

2019-06-19

Start date

2020-01-20

Completion date

2021-04-07

Last updated

2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS

Keywords

PCOS, Astaxanthin, ROS

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.

Interventions

DIETARY_SUPPLEMENTAstaxanthin 8 mg

experimental

OTHERplacebo

Matching placebo pill

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026