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

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ClinicalTrials.gov Identifier: NCT03991286
Recruitment Status : Completed
First Posted : June 19, 2019
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date November 16, 2021
Actual Study Start Date  ICMJE January 20, 2020
Actual Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2021)
Serum and follicular fluid oxidative stress biomarkers levels [ Time Frame: 8 months ]
This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Serum glucose mg/dL levels [ Time Frame: 8 months ]
    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)
  • Serum insulin mIU/ml [ Time Frame: 8 months ]
    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)
  • Serum Folliclestimulating hormone (FSH) mIU/ml levels [ Time Frame: 8 months ]
    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)
  • Serum testosterone testosterone [ Time Frame: 8 months ]
    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)
  • Serum hormone (LH) mIU/ml, [ Time Frame: 8 months ]
    This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Number of oocytes retrieved [ Time Frame: Day1(from the day of oocyte retrieval to fertilization confirmation) ]
    using polarized light microscopy
  • Number of mature(MII) oocyte [ Time Frame: Day1(from the day of oocyte retrieval to fertilization confirmation) ]
    using polarized light microscopy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Astaxanthin on Oxidative Stress Indices in Patients With Polycystic Ovary Syndrome
Official Title  ICMJE The Effect of Astaxanthin on Oxidative Stress Indices in Serum, and Induction of Signaling Pathways in Granulosa Cells in Patients With Polycystic Ovary Syndrome
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE PCOS
Intervention  ICMJE
  • Dietary Supplement: Astaxanthin 8 mg
    experimental
    Other Name: Algalife, Icelandic Astaxanthin
  • Other: placebo
    Matching placebo pill
Study Arms  ICMJE
  • Placebo Comparator: Placebo

    Drug: Placebo

    Ovulatory Agent:

    Clomiphene Citrate

    Intervention: Other: placebo
  • Experimental: experimental

    Drug: Astaxanthin 8mg

    Drug: Ovulatory Agent Clomiphene Citrate

    Intervention: Dietary Supplement: Astaxanthin 8 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2021)
48
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
40
Actual Study Completion Date  ICMJE April 7, 2021
Actual Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991286
Other Study ID Numbers  ICMJE 98-01-30-41687
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Fardin Amidi, professor Tehran University of Medical Sciences
PRS Account Tehran University of Medical Sciences
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP