PCOSNCT03991286
The Effect of Astaxanthin on Oxidative Stress Indices in Patients With Polycystic Ovary Syndrome
A study testing Astaxanthin 8 mg in people with PCOS, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Astaxanthin 8 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- 20 Jan 2020to 7 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Astaxanthin 8 mg, placebo
- Keywords
- PCOS, Astaxanthin, ROS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astaxanthin 8 mgDietary supplement
Also called Algalife, Icelandic Astaxanthin
experimental
placeboOther
Matching placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo
Ovulatory Agent:
Clomiphene Citrate Receives: Other: placebo |
| experimental | Experimental | Drug: Astaxanthin 8mg
Drug: Ovulatory Agent Clomiphene Citrate Receives: Dietary Supplement: Astaxanthin 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum and follicular fluid oxidative stress biomarkers levels
This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)
Measured: 8 months
Secondary outcomes (2)
Number of oocytes retrieved
using polarized light microscopy
Measured: Day1(from the day of oocyte retrieval to fertilization confirmation)
Number of mature(MII) oocyte
using polarized light microscopy
Measured: Day1(from the day of oocyte retrieval to fertilization confirmation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start20 Jan 2020
- Primary completion1 Nov 2020
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fardin Amidi, professor, Study chair, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991286
- Sponsor's protocol ID
- 98-01-30-41687
- Status last verified
- Feb 2020
- First submitted
- 22 May 2019
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35237893
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03991286
- Acronym / sponsor ID
- 98-01-30-41687
- Conditions
- PCOS
- Keywords
- PCOS, Astaxanthin, ROS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placeboDrug: Placebo Ovulatory Agent: Clomiphene Citrate |
| experimental | Experimental | Dietary Supplement: Astaxanthin 8 mgDrug: Astaxanthin 8mg Drug: Ovulatory Agent Clomiphene Citrate |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Astaxanthin 8 mgAlso: Algalife, Icelandic Astaxanthinexperimental | Dietary supplement | experimental |
| placeboMatching placebo pill | Other | Placebo |
Primary outcome
Serum and follicular fluid oxidative stress biomarkers levels
Time frame: 8 months
This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)
2 secondary outcomes
Number of oocytes retrieved
Time frame: Day1(from the day of oocyte retrieval to fertilization confirmation)
Number of mature(MII) oocyte
Time frame: Day1(from the day of oocyte retrieval to fertilization confirmation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Derived from this study: PubMed 35237893Gharaei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fardin Amidi, professor study chair
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin 8 mg in people with PCOS, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum and follicular fluid oxidative stress biomarkers levels (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03991286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.