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Completed

NCT Number: NCT03991286

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

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.

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Key information

Conditions

PCOS

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shariati Hospital

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Astaxanthin 8 mg

Dietary Supplement

experimental

Other names: Algalife, Icelandic Astaxanthin

Placebo

Other

Matching placebo pill

Primary outcomes

  1. Serum and follicular fluid oxidative stress biomarkers levels

    Time frame: 8 months

    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)

Secondary outcomes

  1. Number of oocytes retrieved

    Time frame: Day1(from the day of oocyte retrieval to fertilization confirmation)

    using polarized light microscopy

  2. Number of mature(MII) oocyte

    Time frame: Day1(from the day of oocyte retrieval to fertilization confirmation)

    using polarized light microscopy

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 19, 2019
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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