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

NCT ID: NCT03991286

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-04-07

Brief Summary

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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

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Conditions

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PCOS

Keywords

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PCOS Astaxanthin ROS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Drug: Placebo

Ovulatory Agent:

Clomiphene Citrate

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Matching placebo pill

experimental

Drug: Astaxanthin 8mg

Drug: Ovulatory Agent Clomiphene Citrate

Group Type EXPERIMENTAL

Astaxanthin 8 mg

Intervention Type DIETARY_SUPPLEMENT

experimental

Interventions

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Astaxanthin 8 mg

experimental

Intervention Type DIETARY_SUPPLEMENT

placebo

Matching placebo pill

Intervention Type OTHER

Other Intervention Names

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Algalife, Icelandic Astaxanthin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fardin Amidi, professor

Role: STUDY_CHAIR

Tehran University of Medical Sciences

Locations

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Shariati Hospital

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 35237893 (View on PubMed)

Other Identifiers

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98-01-30-41687

Identifier Type: -

Identifier Source: org_study_id