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

Sponsor
Tehran University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03991286
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
14.6
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Astaxanthin 8 mg
  • Other: placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Jan 20, 2020
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
Apr 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: Placebo Ovulatory Agent: Clomiphene Citrate

Other: placebo
Matching placebo pill
Experimental: experimental

Drug: Astaxanthin 8mg Drug: Ovulatory Agent Clomiphene Citrate

Dietary Supplement: Astaxanthin 8 mg
experimental
Other Names:
  • Algalife, Icelandic Astaxanthin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum and follicular fluid oxidative stress biomarkers levels [8 months]

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

    Secondary Outcome Measures

    1. Number of oocytes retrieved [Day1(from the day of oocyte retrieval to fertilization confirmation)]

      using polarized light microscopy

    2. Number of mature(MII) oocyte [Day1(from the day of oocyte retrieval to fertilization confirmation)]

      using polarized light microscopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shariati Hospital Tehran Iran, Islamic Republic of

    Sponsors and Collaborators

    • Tehran University of Medical Sciences

    Investigators

    • Study Chair: Fardin Amidi, professor, Tehran University of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tehran University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03991286
    Other Study ID Numbers:
    • 98-01-30-41687
    First Posted:
    Jun 19, 2019
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Tehran University of Medical Sciences
    PCOS
    Astaxanthin
    ROS
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome

    Study Results

    No Results Posted as of Nov 16, 2021