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Astaxanthin and AGE-RAGE-Inflammation Axis

Effect of Astaxanthin on Advanced Glycation End Products (AGE)-Receptor for AGE (RAGE)-Inflammation Signaling pathway in Women with Polycystic Ovarian Syndrome-Associated Infertility

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231028059882N2
Enrollment
44
Registered
2024-06-15
Start date
2024-06-21
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovarian Syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: 22 eligible patients will receive 12 mg of astaxanthin (AstaZine®, from BGG) daily (one 4 mg capsule, every 8 hours) for 6 weeks until the day before the ovarian pu

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: Aged between 20 to 38 years old Body mass index (BMI)=24 or anti-mullerian hormone (AMH) >=3.4)

Exclusion criteria

Exclusion criteria: Pregnancy or abortion during the last year before the start of the study History of other endocrinopathies such as adrenal hyperplasia, androgen-secreting tumors, hyperprolactinemia, thyroid dysfunction, diabetes, or impaired glucose tolerance Coexistence of other causes of infertility (severe male factor, tubal factor, uterine factor, endometriosis, Asherman syndrome, diminished ovarian reserves, etc.) Consumption of herbal or traditional medicine, antioxidant supplements, and vitamins within three months before the start of the study Taking ovulation-induction drugs, hormonal agents, and metformin within three months before the start of the study

Design outcomes

Primary

MeasureTime frame
Incidence of ovarian hyperstimulation syndrome (OHSS). Timepoint: From the day of the final ovarian trigger to 7 days after that. Method of measurement: The diagnosis of OHSS will be made by infertility specialist based on clinical, laboratory, and ultrasound findings.;Ovarian Response Indicators. Timepoint: At the day of the final ovarian trigger and oocyte retrieval day. Method of measurement: ultrasound.;Serum levels of estradiol and progesterone hormones. Timepoint: 6 weeks after the intervention beginning at the day of the final ovarian trigger. Method of measurement: ELISA test.

Secondary

MeasureTime frame
Interleukin 6 (IL6) Level in Follicular Fluid (FF). Timepoint: 6 Weeks After the Intervention Beginning. Method of measurement: ELISA test.;Level of Vascular endothelial growth factor (VEGF) in FF. Timepoint: 6 Weeks After the Intervention Beginning. Method of measurement: ELISA test.;Expression Level of Receptor for AGE (RAGE) Gene in Ovarian Granulosa Cells (OGCs). Timepoint: 6 Weeks After the Intervention Beginning. Method of measurement: PCR test.;Inhibitor of Nuclear Factor kappa B - alpha (IkB-a) in OGCs. Timepoint: 6 Weeks After the Intervention Beginning. Method of measurement: Western Blot.;Phosphorylated Inhibitor of Nuclear Factor kappa B - alpha (pIkB-a) in OGCs. Timepoint: 6 Weeks After the Intervention Beginning. Method of measurement: Western Blot.;Severity of OHSS. Timepoint: Up to 7 days of the final trigger drug being given. Method of measurement: The diagnosis of OHSS will be made by infertility specialist based on clinical, laboratory, and ultrasound findings and will be divided to mild, moderate, sever, and critical types.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArezoo Maleki-Hajiagha

Tehran University of Medical Sciences

a-maleki@farabi.tums.ac.ir+98 21 8895 3008

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026