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

NCT03991286 | Completed

• 1 other identifier: 98-01-30-41687
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS

Keywords

PCOS; Astaxanthin; ROS

Outcome Measures

Primary Outcomes (1)

• Serum and follicular fluid oxidative stress biomarkers levels

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

  8 months

Secondary Outcomes (2)

• Number of oocytes retrieved

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

• Number of mature(MII) oocyte

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo Ovulatory Agent: Clomiphene Citrate

Other: placebo

experimental

EXPERIMENTAL

Drug: Astaxanthin 8mg Drug: Ovulatory Agent Clomiphene Citrate

Dietary Supplement: Astaxanthin 8 mg

Interventions

Astaxanthin 8 mg DIETARY_SUPPLEMENT

experimental

Also known as: Algalife, Icelandic Astaxanthin

experimental

placebo OTHER

Matching placebo pill

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Shariati Hospital

Tehran, Iran

Location

Related Publications (1)

• 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.

  PMID: 35237893 DERIVED

MeSH Terms

Interventions

astaxanthine

Study Officials

• Fardin Amidi, professor

  Tehran University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 19, 2019
• Study Start: January 20, 2020
• Primary Completion: November 1, 2020
• Study Completion: April 7, 2021
• Last Updated: November 16, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)