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

Primary Purpose

PCOS

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Astaxanthin 8 mg

placebo

About this trial

This is an interventional basic science trial for PCOS focused on measuring PCOS, Astaxanthin, ROS

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Shariati Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

experimental

Arm Description

Drug: Placebo Ovulatory Agent: Clomiphene Citrate

Drug: Astaxanthin 8mg Drug: Ovulatory Agent Clomiphene Citrate

Outcomes

Primary Outcome Measures

Serum and follicular fluid oxidative stress biomarkers levels

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

Secondary Outcome Measures

Number of oocytes retrieved

using polarized light microscopy

Number of mature(MII) oocyte

using polarized light microscopy

Full Information

NCT ID

NCT03991286

First Posted

May 22, 2019

Last Updated

November 8, 2021

Sponsor

Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03991286

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

January 20, 2020 (Actual)

Primary Completion Date

November 1, 2020 (Actual)

Study Completion Date

April 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PCOS

Keywords

PCOS, Astaxanthin, ROS

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Drug: Placebo Ovulatory Agent: Clomiphene Citrate

Arm Title

experimental

Arm Type

Experimental

Arm Description

Drug: Astaxanthin 8mg Drug: Ovulatory Agent Clomiphene Citrate

Intervention Type

Dietary Supplement

Intervention Name(s)

Astaxanthin 8 mg

Other Intervention Name(s)

Algalife, Icelandic Astaxanthin

Intervention Description

experimental

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

Matching placebo pill

Primary Outcome Measure Information:

Title

Serum and follicular fluid oxidative stress biomarkers levels

Description

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

Time Frame

8 months

Secondary Outcome Measure Information:

Title

Number of oocytes retrieved

Description

using polarized light microscopy

Time Frame

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

Title

Number of mature(MII) oocyte

Description

using polarized light microscopy

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fardin Amidi, professor

Organizational Affiliation

Tehran University of Medical Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Shariati Hospital

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35237893

Citation

Gharaei R, Alyasin A, Mahdavinezhad F, Samadian E, Ashrafnezhad Z, Amidi F. Randomized controlled trial of astaxanthin impacts on antioxidant status and assisted reproductive technology outcomes in women with polycystic ovarian syndrome. J Assist Reprod Genet. 2022 Apr;39(4):995-1008. doi: 10.1007/s10815-022-02432-0. Epub 2022 Mar 3.

Results Reference

derived

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

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