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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Drug: Placebo Ovulatory Agent: Clomiphene Citrate |
|
| experimental | Experimental | Drug: Astaxanthin 8mg Drug: Ovulatory Agent Clomiphene Citrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astaxanthin 8 mg | Dietary Supplement | experimental |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum and follicular fluid oxidative stress biomarkers levels | This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs) | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | using polarized light microscopy | Day1(from the day of oocyte retrieval to fertilization confirmation) |
| Number of mature(MII) oocyte | using polarized light microscopy |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Fardin Amidi, professor | Tehran University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shariati Hospital | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35237893 | Derived | 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. |
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| ID | Term |
|---|---|
| C005948 | astaxanthine |
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| placebo | Other | Matching placebo pill |
|
| Day1(from the day of oocyte retrieval to fertilization confirmation) |