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Astaxanthin improves assisted reproductive technology outcomes in poor ovarian responders through alleviating oxidative stress, inflammation, and apoptosis: a randomized clinical trial.

  • 2024-10-31
  • Journal of ovarian research 17(1)
    • Anahid Shafie
    • Ashraf Aleyasin
    • Mojtaba Saffari
    • Mojtaba Saedi
    • Sahar Rostami
    • Saeede Rezayi
    • Seyed Danial Mohammadi
    • Fardin Amidi

Study Design

Type
Randomized Controlled Trial (RCT)
Population
60 infertile POR patients from POSEIDON Group 4 (age > 35 and poor ovarian reserve)
Methods
Randomized, triple-blind, placebo-controlled trial; 12 mg/day AST or placebo for eight weeks; gonadotropin-releasing hormone antagonist regimen for COS
Blinding
Triple-blind
Duration
eight weeks
Funding
Unclear

Background

Poor ovarian response (POR) to controlled ovarian stimulation (COS) remains challenging, especially in advanced-age women with diminished ovarian reserve, resulting in low live birth rates. Many patients prefer to conceive with their eggs, underscoring the need for improved treatments. This study explores astaxanthin potential as a COS adjuvant to improve ovarian response and assisted reproductive technology (ART) outcomes, considering its impact on oxidative stress (OS), inflammation, and apoptosis, which are key factors in POR.

Methods

In this randomized, triple-blind, placebo-controlled trial, 60 infertile POR patients from POSEIDON Group 4 (the poorest prognosis category, age > 35 and poor ovarian reserve (anti-müllerian hormone < 1.2 ng/ml or antral follicle count < 5) undergoing intracytoplasmic sperm injection were enrolled. Patients were assigned to receive either 12 mg/day AST or placebo for eight weeks. All patients underwent a gonadotropin-releasing hormone antagonist regimen for COS. ART outcomes were compared between groups. Blood serum and follicular fluid (FF) were analyzed for OS markers (superoxide dismutase [SOD], total antioxidant capacity [TAC], and malondialdehyde [MDA]), and pro-inflammatory cytokines (interleukin-6 [IL-6], interleukin-8 [IL-8], and vascular endothelial growth factor [VEGF]) via enzyme-linked immunosorbent assay kits, and cell-free DNA [cfDNA] (apoptotic marker) via ALU quantitative polymerase chain reaction.

Results

After the intervention, the AST group exhibited a significant elevation in serum (P = 0.013) and TAC (P = 0.030), accompanied by a significant reduction in serum MDA (P = 0.005). No significant differences between AST and placebo groups were observed in OS markers in FF. AST group showed significant reductions in the serum IL-6 (P < 0.001), IL-8 (P = 0.001), and VEGF (P = 0.002) levels following AST therapy. In the AST group, FF levels of IL-6 (P = 0 < 001), IL-8 (P = 0.036), VEGF (P = 0.006), and cfDNA (P < 0.001) were significantly lower than in the placebo group. Between-group comparisons showed significant differences in the alterations of serum SOD (P = 0.027), IL-6 (P < 0.001), and IL-8 (P = 0.035) levels between AST and placebo groups. The AST group showed significant increases in the number of retrieved oocytes (P = 0.003), MII oocytes (P = 0.004), frozen embryos (P = 0.037), and high-quality embryos (P = 0.014) compared to the placebo group.

Conclusion

AST shows promise as a COS adjuvant therapy, potentially enhancing some ART outcomes in POR through alleviating OS, inflammation, and apoptosis.

Trial registration

Clinical trial registration number: IRCT20230223057510N1, URL: https://irct.behdasht.gov.ir/trial/68870 , registration date: 2023 March 16.

Research Insights

  • Astaxanthin→Increased Antioxidant Enzyme Levels

    No significant differences between AST and placebo groups were observed in OS markers in FF.

    Effect
    Neutral
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Increased High-Quality Embryo Count

    The AST group showed significant increases in the number of retrieved oocytes (P=0.003), MII oocytes (P=0.004), frozen embryos (P=0.037), and high-quality embryos (P=0.014) compared to the placebo group.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Increased MII Oocyte Count

    The AST group showed significant increases in the number of retrieved oocytes (P=0.003), MII oocytes (P=0.004), frozen embryos (P=0.037), and high-quality embryos (P=0.014) compared to the placebo group.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Increased Number of Frozen Embryo

    The AST group showed significant increases in the number of retrieved oocytes (P=0.003), MII oocytes (P=0.004), frozen embryos (P=0.037), and high-quality embryos (P=0.014) compared to the placebo group.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Increased Retrieved Oocyte Count

    The AST group showed significant increases in the number of retrieved oocytes (P=0.003), MII oocytes (P=0.004), frozen embryos (P=0.037), and high-quality embryos (P=0.014) compared to the placebo group.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Increased Superoxide Dismutase Levels

    After the intervention, the AST group exhibited a significant elevation in serum (P=0.013) and TAC (P=0.030), accompanied by a significant reduction in serum MDA (P=0.005).

    Effect
    Beneficial
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Increased Total Serum Antioxidant Capacity

    No significant differences between AST and placebo groups were observed in OS markers in FF.

    Effect
    Neutral
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Reduced Follicular Fluid Cell-Free DNA Level

    In the AST group, FF levels of IL-6 (P=0 < 001), IL-8 (P=0.036), VEGF (P=0.006), and cfDNA (P<0.001) were significantly lower than in the placebo group.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Reduced Interleukin-1β Levels

    In the AST group, FF levels of IL-6 (P=0 < 001), IL-8 (P=0.036), VEGF (P=0.006), and cfDNA (P<0.001) were significantly lower than in the placebo group.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Reduced Interleukin-6 Levels

    In the AST group, FF levels of IL-6 (P=0 < 001), IL-8 (P=0.036), VEGF (P=0.006), and cfDNA (P<0.001) were significantly lower than in the placebo group.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Reduced Malondialdehyde Level

    No significant differences between AST and placebo groups were observed in OS markers in FF.

    Effect
    Neutral
    Effect size
    Small
    Dose
    12 mg/day
  • Astaxanthin→Reduced Vascular Endothelial Growth Factor Level

    In the AST group, FF levels of IL-6 (P=0 < 001), IL-8 (P=0.036), VEGF (P=0.006), and cfDNA (P<0.001) were significantly lower than in the placebo group.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    12 mg/day
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