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

November 8, 2021 updated by: Tehran University of Medical Sciences

The Effect of Astaxanthin on Oxidative Stress Indices in Serum, and Induction of Signaling Pathways in Granulosa Cells 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of mature(MII) oocyte
Time Frame: Day1(from the day of oocyte retrieval to fertilization confirmation)
using polarized light microscopy
Day1(from the day of oocyte retrieval to fertilization confirmation)
Number of oocytes retrieved
Time Frame: Day1(from the day of oocyte retrieval to fertilization confirmation)
using polarized light microscopy
Day1(from the day of oocyte retrieval to fertilization confirmation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

April 7, 2021

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-01-30-41687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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